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CureSight CS 100

by NovaSight Inc

CureSight CS 100 is a Class II device made by NovaSight Inc, cleared under FDA 510(k) K221375 on 29 Sep 2022 and listed in FDA GUDID since 25 Jun 2025 (UDI-DI 00199284316898), 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) K221375

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 Number00199284316898 UDI-DI Date25 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK221375 Date29 Sep 2022IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221375 decided 29 Sep 2022 Active
  • FDA GUDID UDI-DI 00199284316898 listed 25 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221375
  2. Listed FDA GUDID 00199284316898

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CureSight
Generic name
Dynamic visual acuity testing system
Model / reference
CS 100
Primary DI / UDI-DI
00199284316898
510(k) Number
FDA product code
QQU
GMDN term
Dynamic visual acuity testing system
Device class
Class II
Regulation number
886.5500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dynamic visual acuity testing system

Properties

  • Prescription use
Other properties (14, all answered No)