Cleared Traditional

VISULUX

K161607 · Carl Zeiss Meditec, AG · Ophthalmic
Feb 2017
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K161607 is an FDA 510(k) clearance for the VISULUX, 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 February 23, 2017, 258 days after receiving the submission on June 10, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K161607 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2016
Decision Date February 23, 2017
Days to Decision 258 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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