Identity
- Trade Name
- SWOT FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- CO2 SURGICAL LASER SYSTEM EUDAMED
- Model / Reference
- 002 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972693080024 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972693080024 EUDAMED
- 510(k) Number
- K161356 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Co2 Surgical Laser System by Shanghai Wonderful Opto-Electrics Tech.Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972693080024 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Wonderful Opto-Electrics Tech.Co., Ltd
- EUDAMED SRN
- CN-MF-000027581
- Authorised Representative
- Medwheat Tech Service GmbH DE-AR-000006844
Sources (2)
- EUDAMED 8481fac5-3010-493a-b4bf-a1b20d073b02 61 fields · synced Jun 18, 2026
- FDA UDI 2bf23960-b94d-4392-8534-5c4cab0362c5 33 fields · synced May 30, 2026