Ellex

FDA UDI

Class II (US FDA UDI)

by Ellex Medical Pty Ltd

Identity

Trade Name: Ellex FDA UDI
Generic Name: Indirect binocular laser ophthalmoscope FDA UDI
Device Name: ACC.LIO, L2RG FDA UDI
Model / Reference: 6342810 FDA UDI
Description: ACC.LIO, L2RG FDA UDI

Identifiers

Primary DI / UDI-DI: 09342395001172 FDA UDI
510(k) Number: K081565 FDA UDI
K142398 FDA UDI
FDA Product Code: HQF FDA UDI
GMDN Term: Indirect binocular laser ophthalmoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indirect binocular laser ophthalmoscope

Ellex by Ellex Medical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Indirect binocular laser ophthalmoscope.

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532nm Heine Omega IO with integrated adaptor — QUANTEL MEDICAL · Class II
PASCAL Laser Indirect Ophthalmoscope — Topcon Medical Laser Systems, Inc. · Class II
TruFocus LIO Premiere — Iridex Corporation · Class II
PASCAL Laser Indirect Ophthalmoscope — Topcon Medical Laser Systems, Inc. · Class II
Norlase LION photocoagulator — Norlase Aps · Class II

Cleared under the same submission

K081565 also covers:

Ellex — ELLEX MEDICAL PTY LTD
Ellex — ELLEX MEDICAL PTY LTD
Ellex — ELLEX MEDICAL PTY LTD
Ellex — ELLEX MEDICAL PTY LTD
Integre Duo Pro Red/Green — ELLEX MEDICAL PTY LTD

K142398 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ellex Medical Pty Ltd

Sources (1)

FDA UDI af12223b-7e3b-4596-85e9-b21a1233bc85 34 fields · synced Jun 6, 2026