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EXOCEUTICALS
Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model SZ-22A · UDI-DI 00850062024557
10
510(k) clearances
34
Adverse events
1
Recalls
76
Facilities
Description
The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males whohave Norwood- Hamilton Classifications of lla - V patterns of hair loss and to treat Androgenetic Alopecia and promotehair growth in females who have Ludwig-Savin Scale I-1 to -4. 1l-1. l-2 or ffontal patterns of hair loss: both with Fitzpatrick Skin Types I - 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.