Identity
- Trade Name
- MedArt Intenz FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- Medical CO2 laser system for soft tissue treatments. FDA UDI
- Model / Reference
- MedArt 620 FDA UDI
- Description
- Medical CO2 laser system for soft tissue treatments. FDA UDI
Identifiers
- Catalog Number
- 620.000 FDA UDI
- Primary DI / UDI-DI
- 05700002070609 FDA UDI
- 510(k) Number
- K120573 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
Dimensions & Sizes
- Size
- Weight — 20 Kilogram FDA UDIHeight — 20 Centimeter FDA UDILength — 60 Centimeter FDA UDIDepth — 45 Centimeter FDA UDI
Category: Dermatological carbon dioxide laser system
MedArt Intenz by Medart A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medart A/S
Sources (1)
- FDA UDI d92c61ce-70aa-47fb-9f18-31d41fa461e8 37 fields · synced May 30, 2026