Cleared Traditional

IOLMaster 700

K170171 · Carl Zeiss Meditec, AG · Ophthalmic
Apr 2017
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K170171 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 April 6, 2017, 77 days after receiving the submission on January 19, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K170171 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2017
Decision Date April 06, 2017
Days to Decision 77 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

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