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, LP1RG FDA UDI
Model / Reference: 6340800 FDA UDI
Description: ACC.LIO, LP1RG FDA UDI

Identifiers

Primary DI / UDI-DI: 09342395000861 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

Similar devices

Also classified as Indirect binocular laser ophthalmoscope.

577nm adaptor for Keeler Vantage Plus IO (100µ) — QUANTEL MEDICAL · Class II
577nm Heine Omega 500 IO with integrated adaptor — QUANTEL MEDICAL · Class II
TruFocus LIO Premiere — Iridex Corporation · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ellex Medical Pty Ltd

Sources (1)

FDA UDI c8c46ff9-4966-4ec1-9b88-7ec024fc6cf9 34 fields · synced May 30, 2026