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NOOANCE
Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model M-120 · UDI-DI 06970006970925
10
510(k) clearances
34
Adverse events
1
Recalls
76
Facilities
Description
The NOOANCE LED AND LASER HELME'T is indicated to promote hair growth in males with androgenetic alopeciawho have HamiltonN orwood Classifications of lla-V and Fitzpatrick Classification of Skin Phototypes I to IV. andfemales with androgenetic alopecia who have Ludwig-Savin Classifications of l-ll and Fitzpatrick Classification of SkinPhototypes 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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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.