# Ellex Medical Pty, Ltd.

- Location (FDA's records): Adelaide, South Australia, AU
- FDA decisions: 13 (1997–2022): 13 510(k) clearances
- Product codes: HQF (8), GEX (4), IYO (1)
- Predicates its devices cite: 4 (4 its own); citations of its devices by later devices: 14 (4 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Lightmed Corp.: 2 (https://510kreport.com/company/lightmed)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)
- Alcon Laboratories: 1 (https://510kreport.com/company/alcon-laboratories)
- Topcon Medical Laser Systems, Inc.: 1 (https://510kreport.com/company/topcon-medical-laser-systems)

## Its most-cited devices
- K021550: Lumenis Selecta Duet (2002), cited by 6
- K052777: Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D (2006), cited by 3
- K212630: Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo (2021), cited by 2
- K122202: Ellex 2RT (2013), cited by 1
- K041598: Laserex, Model LP4532 (2004), cited by 1
- K972514: Laserex LP1532 Photocoagulator (1997), cited by 1

## Recent decisions
- K222395: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo (Nov 2, 2022)
- K212630: Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo (Dec 16, 2021)
- K190786: Eye Prime (Apr 11, 2019)
- K142398: Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow (Jul 14, 2015)
- K122202: Ellex 2RT (Jul 1, 2013)
- K081565: Integre Pro, Model L2RY (Jul 2, 2008)
- K080423: Integre, Model LP581 (Mar 11, 2008)
- K052777: Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D (Mar 16, 2006)

Source page: https://510kreport.com/company/ellex-medical