Cleared Traditional

K173371 - VisuMax Femtosecond Laser

K173371 is an FDA 510(k) clearance for VisuMax Femtosecond Laser, manufactured by Carl Zeiss Meditec, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K173371 · Carl Zeiss Meditec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K173371

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 110d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HNO Keratome, Ac-powered

All 56
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K173371.
EPI K Console
K172994 · Moria SA · Oct 2017
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465 · Bausch & Lomb, Inc. · Sep 2006
NORWOOD ABBEY CENTURION SES EPIKERATOME
K051486 · Norwood Abbey , Ltd. · Jul 2005
EPI-K
K043183 · Moria SA · Mar 2005
AMADEUS II EPIKERATOME
K043150 · Sis Ltd., Surgical Instrument Systems · Jan 2005
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083 · Biovision AG · Nov 2004