Ellex Medical Pty, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | November 2, 2022 |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | December 16, 2021 |
| K190786 | Eye Prime | April 11, 2019 |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Ye | July 14, 2015 |
| K122202 | ELLEX 2RT | July 1, 2013 |
| K081565 | INTEGRE PRO, MODEL L2RY | July 2, 2008 |
| K080423 | INTEGRE, MODEL LP581 | March 11, 2008 |
| K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG- | March 16, 2006 |
| K041598 | LASEREX, MODEL LP4532 | October 6, 2004 |
| K021550 | LUMENIS SELECTA DUET | August 9, 2002 |
| K003955 | LASEREX INTEGRE, MODEL LP2532 | March 15, 2001 |
| K992824 | LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPH | November 17, 1999 |
| K972514 | LASEREX LP1532 PHOTOCOAGULATOR | October 3, 1997 |