MedArt Intenz MedArt 620
by Medart A/S
MedArt Intenz MedArt 620 (620.000) is a Class II device made by Medart A/S, cleared under FDA 510(k) K120573 on 13 Jun 2012 and listed in FDA GUDID since 21 Sep 2017 (UDI-DI 05700002070609), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05700002070609 | Date21 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120573 | Date13 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 05700002070609
- FDA 510(k) database K120573
Across registries
- FDA 510(k) K120573 decided 13 Jun 2012 Active
- FDA GUDID UDI-DI 05700002070609 listed 21 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K120573
- Listed FDA GUDID 05700002070609
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MedArt Intenz
- Generic name
- Dermatological carbon dioxide laser system
- Model / Ref / Catalog
- MedArt 620, 620.000
- Primary DI / UDI-DI
- 05700002070609
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological carbon dioxide laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 20 KilogramHeight — 20 CentimeterLength — 60 CentimeterDepth — 45 Centimeter
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