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Dr Naomi
Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model MK-04 · UDI-DI 00856957008022
10
510(k) clearances
107
Adverse events
4
Recalls
133
Facilities
Description
The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles.
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. |
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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.