ISCREEN VISION SCREENER— 510(k) K102651

Substantially Equivalent

Iscreen Vision, Inc.

FDA 510(k) clearance K102651 for ISCREEN VISION SCREENER, Substantially Equivalent on 2011-01-12. Applicant: Iscreen Vision, Inc.. Device class: 2.

Clearance details

Applicant: Iscreen Vision, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2010-09-14
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Cordova, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKI

K253176 — TearView2026-06-22
K251353 — Eyer 22026-01-16
K252120 — Fundus On Phone Non Mydriatic (FOP NM-10)2025-12-12
K250770 — Optina-4C (MHRC-C1N)2025-09-04
K243600 — 3nethra neo HD FA2025-08-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.