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Vision One Red

by Lumenis Be, Inc.

Vision One Red is a Class II device made by Lumenis Be, Inc., cleared under FDA 510(k) K111213 on 25 Jul 2011 and listed in FDA GUDID since 2 Apr 2023 (UDI-DI 00810096330116), active as of 22 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) K111213

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810096330116 UDI-DI Date2 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK111213 Date25 Jul 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111213 decided 25 Jul 2011 Active
  • FDA GUDID UDI-DI 00810096330116 listed 2 Apr 2023 Listed

Recalls

1 recall · FDA

    • Terminated Z-2191-2013 FDA Class II initiated 19 Aug 2013

    Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

Timeline

3 dated events

  1. Cleared FDA 510(k) K111213
  2. Recall initiated FDA recalls Z-2191-2013
  3. Listed FDA GUDID 00810096330116

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vision One
Generic name
Ophthalmic diode laser system
Model / reference
Red
Primary DI / UDI-DI
00810096330116
510(k) Number
FDA product code
GEX
GMDN term
Ophthalmic diode laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic diode laser system

Cleared under the same submission (K111213)

and 2 more cleared under K111213

Similar devices

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

Other devices from Lumenis Be, Inc.

See all devices from Lumenis Be, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)