Home / Device types / Hair removal
Records FDA files under its code for light-based over-the-counter hair removal: handheld laser and intense pulsed light (IPL) devices. One record's quoted indications say the device is for prescription use; that entry carries a Prescription badge.
165 records from 2006 to 2026, filed by 83 companies. 111 device names as filed say IPL or intense pulsed light and 4 say laser. We quote the indications for use for 106 of them from FDA's PDFs.
Quoted from FDA's Product Classification database entry for OHT, checked October 12, 2026.
Each record is one FDA decision about the device named in it, for the use in its indications statement. The company that filed may be the brand on the box or the manufacturer that makes it for the brand.
Records are grouped by FDA product code; a record's own indications can be narrower, broader or different from the group name, so read each one. We quote an indications statement only when it comes from a text page of FDA's PDF (not a scan) and every word checks out; otherwise the entry says why and links the PDF, which is the authority.
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510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 5.
510(k) cleared
“The Sapphire Cooling IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 7), with line breaks removed.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the long-lasting reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Intense Pulsed Light (IPL) System is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The statement's clinical classification text (such as Norwood-Hamilton or Ludwig-Savin ranges) doesn't read cleanly, so we don't quote it rather than guess at a correction. Read FDA's PDF, page 4.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
“IPL400 device is indicated for the removal of unwanted hair. The device is also indicated for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of the treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
Not quoted here. FDA doesn't host a document for this record at the usual address.
510(k) cleared
“IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
“IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 6.
510(k) cleared
“Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
“The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Light Based Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The product is an over-the-counter device intended for removal of unwanted body and facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) clearedPrescription use, per its indications
“The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent hair reduction defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime .”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“Hand-held IPL device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Intense Pulsed Light (IPL) System (Model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K) is an over-the-counter device intended for the removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
“Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
“The IPL Hair Removal Device (Model: AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
“The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
“IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The IPL Hair Removal Device OBT-02 Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
“The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The Superior Hair Remover is an over the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
“IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 5.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
“IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 3.
510(k) cleared
“IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The SmoothSkin BARE+ Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin BARE+ is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6,9,and 12 months after the completion of treatment regimen.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The BRAUN Silk.expert Pro 3 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 3 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6. 9. and 12 months after the completion of a treatment regimen.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
Source discrepancy: this statement names “F60001”, which doesn't appear in the device name in FDA's database. Both are shown exactly as FDA's records have them.
510(k) cleared
“The IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults with Fitzpatrick skin types I – IV.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.
510(k) cleared
“HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The PerfectSmooth is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.
510(k) cleared
“The Wellquest NuBrilliance Pulsed Light Hair Removal system device is an over-the-counter device intended for the removal of unwanted hair. The NuBrilliance Pulsed Light Hair Removal System is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9,a nd 12 months after the completion of the treatment regimen.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The sensiLight™/sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 8.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 5.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 2.