Identity
- Trade Name
- Youlaser CO2 FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Model / Reference
- PGMS00007 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033945934798 FDA UDI
- 510(k) Number
- K123573 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
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
Yes
FDA UDI
Category: Dermatological carbon dioxide laser system
Youlaser CO2 by Quanta System Spa — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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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 | K182669 | Class II | Active |
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Manufacturer
- Manufacturer
- Quanta System Spa
Sources (2)
- FDA UDI 3435b1d8-27e2-4714-bd29-9ae71a8ba30a 57 fields · synced Jun 18, 2026
- FDA 510(k) K182669 1 fields · synced Jun 5, 2026