Cleared Traditional

VisuMax Femtosecond Laser

K173371 · Carl Zeiss Meditec, Inc. · Ophthalmic
Apr 2018
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K173371 is an FDA 510(k) clearance for the VisuMax Femtosecond Laser, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on April 13, 2018, 168 days after receiving the submission on October 27, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K173371 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2017
Decision Date April 13, 2018
Days to Decision 168 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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