Ellex Medical Pty Ltd
Eden Prairie, MN, US
Ellex Medical Pty Ltd appears in FDA device records in Eden Prairie, MN. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Ellex Medical Pty Ltd carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Laserex Systems Inc.enforcement report, recall
- LUMIBIRD MEDICAL, INC.registration
510(k) clearance history
FDA records hold 13 510(k) clearances for Ellex Medical Pty Ltd between 1997 and 2022. The busiest year on record is 2008, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2013 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | HQF | Substantially Equivalent | |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | HQF | Substantially Equivalent | |
| K190786 | Eye Prime | IYO | Substantially Equivalent | |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow | HQF | Substantially Equivalent | |
| K122202 | ELLEX 2RT | HQF | Substantially Equivalent | |
| K081565 | INTEGRE PRO, MODEL L2RY | HQF | Substantially Equivalent | |
| K080423 | INTEGRE, MODEL LP581 | HQF | Substantially Equivalent | |
| K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D | GEX | Substantially Equivalent | |
| K041598 | LASEREX, MODEL LP4532 | HQF | Substantially Equivalent | |
| K021550 | LUMENIS SELECTA DUET | GEX | Substantially Equivalent | |
| K003955 | LASEREX INTEGRE, MODEL LP2532 | GEX | Substantially Equivalent | |
| K992824 | LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL | GEX | Substantially Equivalent | |
| K972514 | LASEREX LP1532 PHOTOCOAGULATOR | HQF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013515803 | 3002806902 | Ellex Medical Pty Ltd | 3-4 Second Avenue, Mawson Lakes South Australia 5095 AU | 2026 | |
| 2133540 | 1000520094 | LUMIBIRD MEDICAL, INC. | 7576 Market Place Dr, EDEN PRAIRIE, MN 55344 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1971-2023 | Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G | When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired. | Class II | Open, Classified | |
| Z-2172-2017 | Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy. | It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient. | Class II | Terminated | |
| Z-1270-2016 | 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 physician eyes while the aiming beam to remain visible. . | The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented. | Class II | Terminated | |
| Z-1844-2011 | Ellex Solo LT5106-S ophthalmic laser (not sold in USA) | Unintended laser emission while the user was moving the joystick for targeting. | Terminated | ||
| Z-1843-2011 | Ellex Tango LT5106-T ophthalmic laser (not sold in USA) | Unintended laser emission while the user was moving the joystick for targeting. | Terminated | ||
| Z-1842-2011 | Alcon 3000LE ophthalmic laser | Unintended laser emission while the user was moving the joystick for targeting. | Terminated | ||
| Z-1841-2011 | Ellex Ultra Q LQP3106-U ophthalmic laser | Unintended laser emission while the user was moving the joystick for targeting. | Terminated | ||
| Z-1840-2011 | Ellex Super Q LQP3106 ophthalmic laser | Unintended laser emission while the user was moving the joystick for targeting. | Terminated | ||
| Z-0578-2010 | Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation. | Potential for two screws important in the design of the safety filter to come loose. | Terminated | ||
| Z-0577-2010 | Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation. | Potential for two screws important in the design of the safety filter to come loose. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain