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FAQ LED Panel

Foreo AB · Model Black · UDI-DI 07640260120600

OHS OLP

510(k) clearances

107

Adverse events

Recalls

129

Facilities

Description

FAQ LED Panels are over-the-counter (OTC) devices intended for the treatment of wrinkles with red+ infrared light and yellow + infrared light, and the treatment of mild to moderate acne with blue+infrared light.

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.