Cleared Traditional

OCULAR RESPONSE ANALYZER

K081756 · Reichert, Inc. · Ophthalmic
Aug 2008
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K081756 is an FDA 510(k) clearance for the OCULAR RESPONSE ANALYZER, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on August 7, 2008, 48 days after receiving the submission on June 20, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K081756 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2008
Decision Date August 07, 2008
Days to Decision 48 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

Similar Devices — HKX Tonometer, Ac-powered

All 57
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
K253039 · Topcon Corporation · Nov 2025
VS Tabletop Tonometer
K223739 · Medimaging Integrated Solution, Inc. · Nov 2023
Intraocular Pressure Tonometer EASYTON
K190382 · Company Elamed · Dec 2019
MiiS Horus Scope DPT 100
K181260 · Medimaging Integrated Solution, Inc (Miis) · Jun 2019
Keeler TonoCare Tonometer
K181143 · Keeler Instruments, Inc. · Feb 2019
Tono Vue Non-Contact Tonometer
K180820 · Crystalvue Medical Corporation · Dec 2018