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CurrentBody Skin™

Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model ZLD-72B · UDI-DI 00850079561014

OAP
10
510(k) clearances
38
Adverse events
1
Recalls
76
Facilities

Description

The CurrentBody Skin™ Dual Light Hair Growth Headband(Model: ZLD-72B) is is indicated to treat Androgenetic Alopecia and to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair-loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, Il-1, II-2 or frontal patterns of hair loss;both within Fitzpatrick skin types 1-V.

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.