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iRestore
Remax Medi-Tech (Shenzhen) Corporation · Model ID-500 · UDI-DI 00859690003897
10
510(k) clearances
34
Adverse events
1
Recalls
76
Facilities
Description
iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood Hamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II . All users should also have Fitzpatrick Skin Types I to IV. The iRestore Hair Growth System uses 51 low-level lasers and 69 light-emitting diodes .
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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