510(k) K052777 ยท GEX Powered Laser Surgical Instrument
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
| Applicant | Ellex Medical Pty, Ltd., Adelaide, South Australia, AU |
| Decision | Substantially Equivalent, Mar 16, 2006 |
| Received | Oct 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2016 | Laserex Systems Inc. Ellex Medical Fixed eye Safety filters Model Integre S LP5532.
The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to Terminated |
HQF | None listed |
| Dec 20, 2007 | Ellex USA Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.