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Solawave
Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model HD-15A · UDI-DI 00850035134887
1
510(k) clearances
54
Adverse events
2
Recalls
62
Facilities
Description
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.