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Ellex Medical Pty Ltd

Australia·AU-MF-000004802

Last updated September 17, 2026

Information

Country: Australia
Address: 3-4, Second Avenue, Mawson Lakes, Australia
Website: www.ellex.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +61 8 7074 8105
PRRC Contact: Rashmi Pillay
EUDAMED SRN: AU-MF-000004802
FDA FEI Number: 3002806902
DUNS Number: —

Catalogue (24)

Device	Model / Reference	Registries	Class	Status
Laserex Lp1532 Photocoagulator	K972514	FDA 510(k)	Class II	Active
Lumenis Selecta Duet	K021550	FDA 510(k)	Class II	Active
Eye Prime	K190786	FDA 510(k)	Class II	Active
Laserex, Model Lp4532	K041598	FDA 510(k)	Class II	Active
Laserex Nd:yag Ophthalmic Laser (lq2106), Alcon Nd:yag Ophthalmic Laser (3000le), Laserex Nd:yag Ophthalmic Laser, Model	K992824	FDA 510(k)	Class II	Active
Laserex Duo Family Of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo Lp1rg-S, Lp1rg-D	K052777	FDA 510(k)	Class II	Active
Laserex Integre, Model Lp2532	K003955	FDA 510(k)	Class II	Active
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo	K222395	FDA 510(k)	Class II	Active
Integre Pro, Model L2ry	K081565	FDA 510(k)	Class II	Active
Integre, Model Lp581	K080423	FDA 510(k)	Class II	Active
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo	K212630	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Integre Pro Green	LP5532	EUDAMEDFDA UDI	Class IIb	Active
Integre Pro Scan Red-Yellow	LP6RY	EUDAMEDFDA UDI	Class IIb	Active
Integre Pro Scan Green	LP6G	EUDAMEDFDA UDI	Class IIb	Active
2rt	LR1532	EUDAMEDFDA UDI	Class IIb	Active
Tango Neo	Tango Neo	EUDAMEDFDA UDI	Class IIb	Active
Integre Pro Red-Yellow	L2RY	EUDAMEDFDA UDI	Class IIb	Active
Tango Reflex Neo	Tango Reflex Neo	EUDAMEDFDA UDI	Class IIb	Active
Ultra Q	LQP3106‐U	EUDAMEDFDA UDI	Class IIb	Active
Ultra Q Reflex	LQP3106‐U	EUDAMEDFDA UDI	Class IIb	Active
Solo	LT5106-S	EUDAMEDFDA UDI	Class IIb	Active
Integre Pro Scan Yellow	LP6Y	EUDAMEDFDA UDI	Class IIb	Active
UltraQ Reflex Neo	UltraQ Reflex Neo	EUDAMEDFDA UDI	Class IIb	Active
Integre Pro Yellow	LP561	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

E C Rep Limited IE

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 16, 2023	Z-1971-2023	—	open, classified	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.
Feb 15, 2011	Z-1840-2011	—	terminated	Unintended laser emission while the user was moving the joystick for targeting.
Feb 15, 2011	Z-1841-2011	—	terminated	Unintended laser emission while the user was moving the joystick for targeting.
Feb 15, 2011	Z-1843-2011	—	terminated	Unintended laser emission while the user was moving the joystick for targeting.
Feb 15, 2011	Z-1842-2011	—	terminated	Unintended laser emission while the user was moving the joystick for targeting.
Feb 15, 2011	Z-1844-2011	—	terminated	Unintended laser emission while the user was moving the joystick for targeting.
Feb 11, 2009	Z-0577-2010	—	terminated	Potential for two screws important in the design of the safety filter to come loose.
Feb 11, 2009	Z-0578-2010	—	terminated	Potential for two screws important in the design of the safety filter to come loose.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Ellex Medical Pty Ltd US