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Optego 4000016

by Optego Vision USA, Inc.

Optego 4000016 is a Class II device made by Optego Vision USA, Inc., cleared under FDA 510(k) K112832 on 5 Dec 2011 and listed in FDA GUDID since 17 Mar 2022 (UDI-DI 00360843002938), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K112832

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 Number00360843002938 UDI-DI Date17 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112832 Date5 Dec 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112832 decided 5 Dec 2011 Active
  • FDA GUDID UDI-DI 00360843002938 listed 17 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112832
  2. Listed FDA GUDID 00360843002938

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optego
Generic name
Contact lens case
Model / reference
4000016
Primary DI / UDI-DI
00360843002938
510(k) Number
FDA product code
LRX
GMDN term
Contact lens case
Device class
Class II
Regulation number
886.5928
GUDID distribution status
In Commercial Distribution

Related devices

Category: Contact lens case

Cleared under the same submission (K112832)

and 5 more cleared under K112832

Similar devices

Other devices filed under FDA product code LRX (Case, Contact Lens).

Other devices from Optego Vision USA, Inc.

See all devices from Optego Vision USA, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)