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Professional Red

QUASAR BIO-TECH INC. · Model DPA-004Red · UDI-DI 00851478007103

OHS

510(k) clearances

107

Adverse events

Recalls

133

Facilities

Description

The Quasar Professional Red Light Therapy device enables you to provide essential treatments to rebuild clients’ collagen and elastin. Smooth the skin and reduce wrinkles with the most powerful tools available outside the doctors’ offices.

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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Data 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.