Identifiers
- 510(k) Number
- K152199 FDA 510(k)
- FDA Product Code
- NFO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RejuvatoneMD is a transcutaneous electrical stimulator intended for aesthetic purposes. It functions by delivering electrical stimulation to the skin.
This device is classified as a Class 2 medical device under regulation number 882.5890. It has received FDA 510(k) clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152199 | Class II | Active |
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Manufacturer
- Manufacturer
- Trophy Skin, Inc.
Sources (1)
- FDA 510(k) K152199 24 fields · synced Sep 23, 2026