Home › Shenzhen Kaiyan Medical Equipment Co,. Ltd › CurrentBody Skin™
CurrentBody Skin™
Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model ZC-05 · UDI-DI 00655729008426
10
510(k) clearances
100
Adverse events
4
Recalls
129
Facilities
Description
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-29 | Quasar Bio-Tech, Inc. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| 2018-06-29 | Quasar Bio-Tech, Inc. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| 2018-06-29 | Quasar Bio-Tech, Inc. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| 2008-06-18 | Sybaritic, Inc | Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.