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Diode Laser Cap

Cosmo Far East Technology Limited · Model COSMO-020 · UDI-DI 06973416570204

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

Description

Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

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.