Facility

Ellex Medical Pty Ltd

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002806902
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	3-4 Second Avenue Mawson Lakes South Australia, AU 5095
Registration status	Active · expires 2026
Parent company	Ellex Medical (owner-operator 9010469)
Brand names	Laserex 3000LX; Laserex LQP3106; Super Q; Alcon 3000LE; Coherent Aura

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IIOngoing2023-03-16
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.

FDA inspections (1)

NAI2018-05-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Ellex Medical

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Ellex Medical Pty Ltd (FEI 3002806902) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806902-ellex-medical-pty-ltd/

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