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iScreen Vision iScreen Vision Screener 3000

by Iscreen Vision Inc.

iScreen Vision iScreen Vision Screener 3000 is a Class II device made by Iscreen Vision Inc., cleared under FDA 510(k) K102651 on 12 Jan 2011 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00864218000104), active as of 22 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 22 Oct 2026

Documents

510(k) K102651

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 Number00864218000104 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK102651 Date12 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102651 decided 12 Jan 2011 Active
  • FDA GUDID UDI-DI 00864218000104 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102651
  2. Listed FDA GUDID 00864218000104

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iScreen Vision
Generic name
External ocular measurement camera
Model / reference
iScreen Vision Screener 3000
Primary DI / UDI-DI
00864218000104
510(k) Number
FDA product code
HKI
GMDN term
External ocular measurement camera
Device class
Class II
Regulation number
886.1120
GUDID distribution status
In Commercial Distribution

Related devices

Category: External ocular measurement camera

Similar devices

Other devices filed under FDA product code HKI (Camera, Ophthalmic, Ac-Powered).

Other devices from Iscreen Vision Inc.

Properties

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