Home / Device types / Hair growth
Records FDA files under its hair-growth laser code: caps, helmets, bands and combs. FDA's code name doesn't say over-the-counter, and some records are for professional systems, so read each record. One record's quoted indications say the device is for prescription use; that entry carries a Prescription badge.
114 records from 2007 to 2026, filed by 60 companies. 29 device names as filed mention a cap, helmet, hat or band, and 17 a comb or brush. We quote the indications for use for 38 of them from FDA's PDFs.
Quoted from FDA's Product Classification database entry for OAP, 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. 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
“CHZL Red Light Therapy Hair Growth Cap (Model(s): CHZL-120BK-L52D,CHZL-120BKL53D,CHZL-120BK-L54D) is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV. The device is intended for use in adults (22 years of age and older).”
Copied from the text of FDA's 510(k) document (PDF, page 6), 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 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 4.
510(k) cleared
“The device is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.”
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 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 4.
510(k) cleared
“The device are indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have NorwoodHamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”
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
“Hair Growth Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
“The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.”
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 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 4.
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
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 4.
510(k) cleared
“Breo Laser Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.”
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
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
“Revian Lyte is intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 6), 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
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
“Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.”
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 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
“Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV. ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.”
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
“Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”
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. 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 3.
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
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. 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. FDA doesn't host a document for this record at the usual address.
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 4.
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 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 3.
510(k) cleared
“The LaserCap Family of Lasers, models 300, 224, 120 and 80 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, and males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Skin Phototypes I to 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
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
“Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“CAPOGEN Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.”
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 3.
510(k) cleared
“The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
Source discrepancy: this statement names “KN-8000B”, “KN-8000C”, “KN-8000D”, “KN-8000E”, which don't appear in the device name in FDA's database. Both are shown exactly as FDA's records have them.
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 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 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
“Laser Hair Growth Cap is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), 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
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
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) clearedPrescription use, per its indications
“The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
Source discrepancy: this statement names “KN-8000A”, 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 iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, males who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), 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 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 Kiierr Family of Devices, the 272 and 148 Laser Devices are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The SuperGrow 272 laser hat and the Ultimate 272 are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood – Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I‐1 to I‐4, II‐1, II‐2, or frontal; both with Fitzpatrick Skin Types I to IV.”
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'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 3.
510(k) cleared
“The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V, females who have Ludwig-Savin Classifications of I – II or Frontal and for both, Fitzpatrick Skin Phototypes I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.
510(k) cleared
“The Hair Up is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), 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
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
“Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“REVIAN RED is indicated to treat Androgenetic Alopecia and promote hair growth in males who have NorwoodHamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”
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 Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.”
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 SuperGrow 272 laser hat and the Ultimate 272 are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood – Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to 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
“The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to 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
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 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
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 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 Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V ; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.”
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 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 3.
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 3.
510(k) cleared
“The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.”
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. 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. 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 igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
“The HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, …”
“The HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV. The HairMax LaserComb 82 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.”
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
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
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 7.
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. 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.
510(k) cleared
Not quoted here. FDA doesn't host a document for this record at the usual address.
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
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.
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.