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Hair Laser Helmet

PULSADERM LLC · Model RB2040 · UDI-DI 00858830007191

OAP
10
510(k) clearances
34
Adverse events
1
Recalls
76
Facilities

Description

Laser Device for promotion of hair growth.

Recalls

DateFirmReason
2022-09-01OMM Imports, Inc. dba Zero GravityThe 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.