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iRestore
Remax Medi-Tech (Shenzhen) Corporation · Model ID-500 · UDI-DI 00859690003361
10
510(k) clearances
38
Adverse events
1
Recalls
76
Facilities
Description
The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV. The iRestore Hair Growth System uses 21 low-level lasers and 30 light emitting diodes (LED).
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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