Identity
- Trade Name
- CO2 Laser Therapy Machine FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Model / Reference
- FG 900-C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970453270128 FDA UDI
- 510(k) Number
- K161925 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological carbon dioxide laser system
CO2 Laser Therapy Machine by Beijing ADSS Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Beijing ADSS Development Co., Ltd.
Sources (1)
- FDA UDI 4e649a3b-46a9-4aa5-9e56-c16ab41785d1 33 fields · synced Jun 6, 2026