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Tanda Beauty Canada, Inc · Model Series 15 · UDI-DI 00806248007425
10
510(k) clearances
107
Adverse events
4
Recalls
134
Facilities
Description
Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region. This is a tester device.
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.