QuardoStar PRO 1490
by Asclepion Laser Technologies GmbH
QuardoStar PRO 1490 is a Class II device made by Asclepion Laser Technologies GmbH, cleared under FDA 510(k) K133297 on 10 Jun 2014 and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 04058784000026), 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 | Number04058784000026 | Date17 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133297 | Date10 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 04058784000026
- FDA 510(k) database K133297
Across registries
- FDA 510(k) K133297 decided 10 Jun 2014 Active
- FDA GUDID UDI-DI 04058784000026 listed 17 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K133297
- Listed FDA GUDID 04058784000026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuardoStar PRO
- Generic name
- General/multiple surgical diode laser system
- Model / reference
- 1490
- Primary DI / UDI-DI
- 04058784000026
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General/multiple surgical diode laser system.