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Ellex 6342800

by Ellex Medical Pty Ltd

Ellex 6342800 is a Class II device made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K142398 on 14 Jul 2015 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 09342395001165), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09342395001165 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK142398 Date14 Jul 2015IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142398 decided 14 Jul 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 09342395001165 listed 24 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1971-2023 FDA Class II initiated 16 Mar 2023

    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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K081565
  2. Cleared FDA 510(k) K142398
  3. Listed FDA GUDID 09342395001165
  4. Recall initiated FDA recalls Z-1971-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ellex
Generic name
Indirect binocular laser ophthalmoscope
Model / reference
6342800
Primary DI / UDI-DI
09342395001165
510(k) Number
FDA product code
HQF
GMDN term
Indirect binocular laser ophthalmoscope
Device class
Class II
Regulation number
886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Indirect binocular laser ophthalmoscope

Cleared under the same submission (K081565)

and 1 more cleared under K081565

Cleared under the same submission (K142398)

and 1 more cleared under K142398

Similar devices

Other devices filed under FDA product code HQF (Laser, Ophthalmic).

Other devices from Ellex Medical Pty Ltd

See all devices from Ellex Medical Pty Ltd →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)