Identity
- Trade Name
- M22TM Q-Switched Nd:YAG 2mm Metal Treatment Tip EUDAMEDM22™ Q-Switched 2mm Metal Treatment Tip Kit FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Model / Reference
- NA EUDAMEDKT-10024880Be EUDAMEDM22™ Q-Switched 2mm Metal Treatment Tip Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290117770498 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011777QSWTPLY EUDAMED
- 510(k) Number
- K193500 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
KT-10024880Be by Lumenis Be Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729011777QSWTPLY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Lumenis Be LTD
- EUDAMED SRN
- IL-MF-000022063
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (3)
- EUDAMED 38f2168e-93ba-4784-be53-f80f0a7047e3 61 fields · synced Jul 10, 2026
- FDA UDI c576a0a0-a10b-4385-90a7-1a25be058e00 33 fields · synced May 24, 2026
- EUDAMED 5d9db31d-afdb-44e4-be79-af4b19640a14 61 fields · synced Jul 10, 2026