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NEWHAIR LASER HAIR GROWTH CAP

Shang Far Biotechnology Co. · Model TW280 · UDI-DI 04719892822800

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

Description

Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 280 laser diodes. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.

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.