Cleared Traditional

IOLMaster 700

K173771 · Carl Zeiss Meditec, AG · Ophthalmic
Aug 2018
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K173771 is an FDA 510(k) clearance for the IOLMaster 700, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on August 24, 2018, 256 days after receiving the submission on December 11, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K173771 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2017
Decision Date August 24, 2018
Days to Decision 256 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

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
SLM-1ER, SLM-2ER, SLM-3ER
K171877 · Chongqing Kanghua Ruiming S&T Co., Ltd. · Dec 2017
Digital Eye Anterior Camera
K170470 · Medimaging Integrated Solution, Inc (Miis) · Oct 2017