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Hair Growth Device
Dongguan Boyuan Intelligent Technology Co.,Ltd · Model KCA451-200S · UDI-DI 06977638360483
1
510(k) clearances
38
Adverse events
1
Recalls
77
Facilities
Description
Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with and rogenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to 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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