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GetHairMD
Revian, Inc. · Model 10000-10013 · UDI-DI 00850003374161
1
510(k) clearances
34
Adverse events
1
Recalls
76
Facilities
Description
This is a private label device. The device is Revian's design P/N 10000-10001 (K173729) with modified GetHairMD logos and colors for private labeling. There are no other differences between the products.
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.