Ellex 6339520
Ellex 6339520 is a Class II device made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K041598 on 6 Oct 2004 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 09342395000694), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09342395000694 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041598 | Date6 Oct 2004 | StatusActive |
Official records
- AccessGUDID record 09342395000694
- FDA 510(k) database K041598
Across registries
- FDA 510(k) K041598 decided 6 Oct 2004 Active
- FDA GUDID UDI-DI 09342395000694 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0286-2008
Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.
Timeline
- Cleared FDA 510(k) K041598
- Recall initiated FDA recalls Z-0286-2008
- Listed FDA GUDID 09342395000694
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ellex
- Generic name
- Ophthalmic solid-state laser system
- Model / reference
- 6339520
- Primary DI / UDI-DI
- 09342395000694
- 510(k) Number
- FDA product code
- HQF
- GMDN term
- Ophthalmic solid-state laser system
- Device class
- Class II
- Regulation number
- 886.4390
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic solid-state laser system.