Home › Shang Far Biotechnology Co. › NEWHAIR LASER HAIR GROWTH CAP
NEWHAIR LASER HAIR GROWTH CAP
Shang Far Biotechnology Co. · Model TW280 · UDI-DI 04719892822800
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
| 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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Get your free API keyRead the docsData 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.
