Home / Device types / RF for wrinkles
Records FDA files under its code for over-the-counter radiofrequency wrinkle devices: handheld devices that heat the skin with radiofrequency energy.
12 records from 2015 to 2026, filed by 5 companies, including 1 De Novo grant (DEN150005). We quote the indications for use for 5 of them from FDA's PDFs.
Quoted from FDA's Product Classification database entry for PAY, checked October 12, 2026.
The regulation for this code requires the labeling to carry “A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.” (21 CFR 878.4420).
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. 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. 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 CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
Source discrepancy: this statement names “ST030”, 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 Silk’n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have 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 STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have 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 STOP U device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-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.
De Novo granted
“The EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.”
Copied from the text of FDA's decision summary (PDF, page 1), with line breaks removed.