Cleared Traditional

K173371 - VisuMax Femtosecond Laser (FDA 510(k) Clearance)

Class I Ophthalmic device.

K173371 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
168d
Days
Class 1
Risk

K173371 is an FDA 510(k) clearance for the VisuMax Femtosecond Laser. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on April 13, 2018 after a review of 168 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Carl Zeiss Meditec, Inc. devices

Submission Details

510(k) Number K173371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 110d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.