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M22 Q-Switch Lens Assembly & 6mm Metal Treatment Tip Kit
FDA UDIClass II (US FDA UDI)
by Lumenis
Identity
- Trade Name
- M22 Q-Switch Lens Assembly & 6mm Metal Treatment Tip Kit FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Model / Reference
- M22 Q-Switch Lens Assembly & 6mm Metal Treatment Tip Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109142258 FDA UDI
- FDA Product Code
- GEX FDA UDIONG FDA UDIONF FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
The M22 Q-Switch Lens Assembly & 6mm Metal Treatment Tip Kit is a comprehensive multi-modality skin surface treatment system designed for ablative and non-ablative treatments of the skin. This device features an electrically-powered assembly of devices, including lasers, lamps, and dedicated applicators, intended to apply various therapies to the skin surface.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lumenis
Sources (1)
- FDA UDI 67026ff8-61e6-4f74-b5a8-2bd8cbc79265 34 fields · synced Oct 6, 2026