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Pure Rayz Teal
QUASAR BIO-TECH INC. · Model DPA-026-PRTEAL · UDI-DI 00851478007141
10
510(k) clearances
107
Adverse events
4
Recalls
131
Facilities
Description
As we age, the production of collagen and elastin — the key building blocks of healthy skin — in the body slows. Medical science proves the production of new collagen and elastin result from the combination of red, super red, amber, and infrared light upon application to affected skin. PureRayz has a specific initial treatment time and after eight weeks, only minimal touch-ups are needed to sustain the results. Three minutes per area is all it takes to start achieving noticeable results.
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.