Skip to content

Ellex 6328990

by Ellex Medical Pty Ltd

Ellex 6328990 is a Class II device made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K122202 on 1 Jul 2013 (3 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 09342395000588), 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

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09342395000588 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK122202 Date1 Jul 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122202 decided 1 Jul 2013 Active· +3 more in the status table
  • FDA GUDID UDI-DI 09342395000588 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0286-2008 FDA Unclassified (pre-2012) initiated 13 Jun 2007

    Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.

Timeline

6 dated events

  1. Cleared FDA 510(k) K992824
  2. Cleared FDA 510(k) K021550
  3. Cleared FDA 510(k) K041598
  4. Recall initiated FDA recalls Z-0286-2008
  5. Cleared FDA 510(k) K122202
  6. Listed FDA GUDID 09342395000588

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  • Withdrawn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
Laser beam eye protector, patient
Model / reference
6328990
Primary DI / UDI-DI
09342395000588
FDA product code
GEX, HQF
GMDN term
Laser beam eye protector, patient
Device class
Class II
Regulation number
878.4810, 886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laser beam eye protector, patient

Cleared under the same submission (K021550)

Cleared under the same submission (K041598)

and 8 more cleared under K041598

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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)