The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.
Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO, 1)
PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
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.
“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.”
“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.”
“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.”
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.