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iHelmet
Shenzhen Slinph Technology Co., Ltd. · Model LTD200S · UDI-DI 06971008070019
1
510(k) clearances
34
Adverse events
1
Recalls
76
Facilities
Description
iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila - V and for both, Fitzpatrick Classification of Skin Phototypes of l - 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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