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HIGHERDOSE
Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model HG-120K · UDI-DI 00850049532440
10
510(k) clearances
38
Adverse events
1
Recalls
76
Facilities
Description
The HIGHERDOSE Red Light Hat is a home wearable light-emiting diode phototherapy device withproven wavelengths of light 650nm+10nm Red light, which are used to treat Androgenetic Alopecia andpromote hair growth in males who have Norwood- Hamilton Classifications of lla - V patterns of hair lossand to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1to 1-4, 1l-1, ll-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types l - IV.
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.