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IPL Hair Removal Device, Model(s): skn001, skn005, skn006, skn002, RoseSkinCo L…
FDA 510(k)Class II (US FDA 510(k))
510(k) K222537
Identifiers
- 510(k) Number
- K222537 FDA 510(k)
- FDA Product Code
- OHT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
IPL Hair Removal Device, Model(s): skn001, skn005, skn006, skn002, RoseSkinCo L… by Shenzhen Ishine Technology Company Limited — Class II — FDA_510K — listed…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222537 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Ishine Technology Company Limited
Sources (1)
- FDA 510(k) K222537 24 fields · synced Jun 18, 2026