Company ยท AU
Ellex Medical Pty, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2022. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 2, 2022 | K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo Ellex Medical Pty, Ltd., AU | HQF |
| Dec 16, 2021 | K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo Ellex Medical Pty, Ltd., AU | HQF |
| Apr 11, 2019 | K190786 | Eye Prime Ellex Medical Pty, Ltd., AU | IYO |
| Jul 14, 2015 | K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow Ellex Medical Pty, Ltd., AU | HQF |
| Jul 1, 2013 | K122202 | ELLEX 2RT Ellex Medical Pty, Ltd., AU | HQF |
| Jul 2, 2008 | K081565 | INTEGRE PRO, MODEL L2RY Ellex Medical Pty, Ltd., AU | HQF |
| Mar 11, 2008 | K080423 | INTEGRE, MODEL LP581 Ellex Medical Pty, Ltd., AU | HQF |
| Mar 16, 2006 | K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D Ellex Medical Pty, Ltd., AU | GEX |
| Oct 6, 2004 | K041598 | LASEREX, MODEL LP4532 Ellex Medical Pty, Ltd., AU | HQF |
| Aug 9, 2002 | K021550 | LUMENIS SELECTA DUET Ellex Medical Pty, Ltd. | GEX |
| Mar 15, 2001 | K003955 | LASEREX INTEGRE, MODEL LP2532 Ellex Medical Pty, Ltd., AU | GEX |
| Nov 17, 1999 | K992824 | LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL Ellex Medical Pty, Ltd., AU | GEX |
| Oct 3, 1997 | K972514 | LASEREX LP1532 PHOTOCOAGULATOR Ellex Medical Pty, Ltd., AU | HQF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2023 | Ellex Medical Pty Ltd. Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532
Spare, Optics Bench V2, L2G/LP6G Open, Classified |
HQF | K081565 K142398 |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Solo LT5106-S ophthalmic laser (not sold in USA) Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Tango LT5106-T ophthalmic laser (not sold in USA) Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Alcon 3000LE ophthalmic laser Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Ultra Q LQP3106-U ophthalmic laser Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Super Q LQP3106 ophthalmic laser Terminated |
HQF | None listed |
| Jan 20, 2010 | Ellex Medical Pty Ltd Motorised Safety Filter, Wild; Model number 6339590.
Intended for photocoagulation. Terminated |
HQF | None listed |
| Jan 20, 2010 | Ellex Medical Pty Ltd Ellex Motorised Safety Filter, Zeiss; Model number 6339585.
Intended for photocoagulation. Terminated |
HQF | None listed |