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Ellex 6335740

by Ellex Medical Pty Ltd

Ellex 6335740 is a Class II device made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K081565 on 2 Jul 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 09342395000625), 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

510(k) K081565

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09342395000625 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK081565 Date2 Jul 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081565 decided 2 Jul 2008 Active
  • FDA GUDID UDI-DI 09342395000625 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

3 dated events

  1. Cleared FDA 510(k) K081565
  2. Listed FDA GUDID 09342395000625
  3. 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  • Withdrawn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
Ophthalmic solid-state laser system, photodisruption
Model / reference
6335740
Primary DI / UDI-DI
09342395000625
510(k) Number
FDA product code
HQF
GMDN term
Ophthalmic solid-state laser system, photodisruption
Device class
Class II
Regulation number
886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic solid-state laser system, photodisruption

Cleared under the same submission (K081565)

and 1 more cleared under K081565

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)