Cleared Traditional

SLIT LAMP, H-201

K936209 · Canon USA, Inc. · Ophthalmic
Apr 1994
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K936209 is an FDA 510(k) clearance for the SLIT LAMP, H-201, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on April 1, 1994, 93 days after receiving the submission on December 29, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K936209 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1993
Decision Date April 01, 1994
Days to Decision 93 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

Similar Devices — HJO Biomicroscope, Slit-lamp, Ac-powered

All 106
HP-OCT (HP-OCT)
K231760 · Cylite Pty. , Ltd. · Mar 2024
Kowa SL-19
K222372 · Kowa Company , Ltd. · Nov 2022
MiiS Horus Eye Anterior Camera
K193188 · Medimaging Integrated Solution, Inc (Miis) · Jan 2020
Sunkingdom Slit Lamp
K182306 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Nov 2018
IOLMaster 700
K173771 · Carl Zeiss Meditec, AG · Aug 2018
SLM-1ER, SLM-2ER, SLM-3ER
K171877 · Chongqing Kanghua Ruiming S&T Co., Ltd. · Dec 2017