Celluma

Biophotas, Inc. · Model MYSTIQUE · UDI-DI 00850523007365

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Celluma device delivers light in the blue and red spectrum, and heat in the IR spectrum, to treat full face wrinkles, acne vulgaris and red light to promote hair growth. The device has 3 main modes Wrinkles, Acne and Hair and the Hair mode can be used singly or in combination with Wrinkles or Acne.

Recalls

Date	Firm	Reason
2022-09-01	OMM Imports, Inc. dba Zero Gravity	The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information

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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.