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.