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Glaucoma Module 1.00

by Topcon Healthcare Solutions, Inc.

Glaucoma Module 1.00 is a Class II device made by Topcon Healthcare Solutions, Inc., cleared under FDA 510(k) K200954 on 3 Aug 2020 and listed in FDA GUDID since 26 Feb 2021 (UDI-DI 00850003069135), 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) K200954

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 Number00850003069135 UDI-DI Date26 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200954 Date3 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200954 decided 3 Aug 2020 Active
  • FDA GUDID UDI-DI 00850003069135 listed 26 Feb 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200954
  2. Listed FDA GUDID 00850003069135

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Glaucoma Module
Generic name
Camera application software
Model / reference
1.00
Primary DI / UDI-DI
00850003069135
510(k) Number
FDA product code
NFJ
GMDN term
Camera application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Camera application software

Similar devices

Other devices filed under FDA product code NFJ (System, Image Management, Ophthalmic).

Other devices from Topcon Healthcare Solutions, Inc.

See all devices from Topcon Healthcare Solutions, Inc. →

Properties

Other properties (15, all answered No)