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Ellex 6339510

by Ellex Medical Pty Ltd

Ellex 6339510 is a Class II device made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K041598 on 6 Oct 2004 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 09342395000687), 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

510(k) K041598

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 Number09342395000687 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041598 Date6 Oct 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041598 decided 6 Oct 2004 Active
  • FDA GUDID UDI-DI 09342395000687 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

3 dated events

  1. Cleared FDA 510(k) K041598
  2. Recall initiated FDA recalls Z-0286-2008
  3. Listed FDA GUDID 09342395000687

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  • Withdrawn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
6339510
Primary DI / UDI-DI
09342395000687
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 (K041598)

and 8 more cleared under K041598

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)