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Ellex Medical Pty Ltd: FDA-registered device maker in Mawson Lakes South Australia, Australia, 10 510(k) clearances

Name: Ellex Medical Pty Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ellex Medical Pty Ltd is registered with the FDA (registration 3013515803) in Mawson Lakes South Australia, Australia. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 2, 2022. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Ellex Medical Pty Ltd

FDA registration number: 3013515803
FEI number: 3002806902
Address: 3-4 Second Avenue, Mawson Lakes South Australia, Australia, 5095
Owner or operator: Ellex Medical (9010469)
Roles: Complaint file establishment, Manufacturer
First device listed: May 16, 2000
Registered through: 2026
Brand names listed: Alcon 3000LE, Coherent Aura, EYE CUBED System -ABD Diagnostic Ultrasound, Ellex Total Solution Tables, Eye Cubed New Generation, Eye Cubed V4, Eye Cubed-ABDU Diagnostic Ultrasound, Eye One Diagnostic Ultrasound System and more

Devices it lists

Device	Product code	Class	Role	Source
Laser, Ophthalmic	HQF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Table, Instrument, Powered, Ophthalmic	HRJ	1	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 2, 2022	K222395	Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo	HQF	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
December 16, 2021	K212630	Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo	HQF	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
April 11, 2019	K190786	Eye Prime	IYO	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
July 14, 2015	K142398	Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow	HQF	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
December 27, 2010	K103608	I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND	IYO	Substantially Equivalent	Ellex, Inc.	accessdata.fda.gov
July 2, 2008	K081565	INTEGRE PRO, MODEL L2RY	HQF	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
March 16, 2006	K052777	LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D	GEX	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
October 6, 2004	K041598	LASEREX, MODEL LP4532	HQF	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
August 9, 2002	K021550	LUMENIS SELECTA DUET	GEX	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov
November 17, 1999	K992824	LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL	GEX	Substantially Equivalent	Ellex Medical Pty, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 16, 2023	92532	Class II	Ongoing	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.	accessdata.fda.gov
February 1, 2016	73468	Class II	Terminated	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 th	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.	accessdata.fda.gov
February 15, 2011	58076	Not yet classified	Terminated	Ellex Super Q LQP3106 ophthalmic laser	Unintended laser emission while the user was moving the joystick for targeting.	accessdata.fda.gov
February 11, 2009	54019	Not yet classified	Terminated	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.	accessdata.fda.gov

Compare with other makers

Updated June 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.