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iRestore
Remax Medi-Tech (Shenzhen) Corporation · Model ID-510 · UDI-DI 00859690003910
10
510(k) clearances
38
Adverse events
1
Recalls
77
Facilities
Description
The iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes 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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