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Celluma

Biophotas, Inc. · Model RESTORE C/US · UDI-DI 00850523007136

OHS ILY OAP

510(k) clearances

100

Adverse events

Recalls

129

Facilities

Description

3 mode device. Hair, Wrinkles, Aches & Pains

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.