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Trophy Skin, Inc.

3 FDA records filed under this company name, from 2014 to 2016, in microcurrent and ems (NFO, 1), hair growth (OAP, 1), light for wrinkles (OHS, 1).

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)

510(k) cleared

RejuvatoneMD

510(k) number
K152199
Applicant
Trophy Skin, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 1)

510(k) cleared

HairMD

510(k) number
K152019
Applicant
Trophy Skin, Inc.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

LED and light devices for wrinkles (OHS, 1)

510(k) cleared

REJUVALITE MD

510(k) number
K133896
Applicant
Trophy Skin, Inc.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Rejuvalite MD is an Over the Counter device that is intended for the use in the treatment of full face wrinkles.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.