Cleared Traditional

K171014 - VICTUS Femtosecond Laser Platform

K171014 is the FDA 510(k) clearance for VICTUS Femtosecond Laser Platform by Technolas Perfect Vision GmbH. It is a Class 2 Ophthalmic device (product code OOE) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K171014 · Technolas Perfect Vision GmbH · Ophthalmic device
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Oct 2017
Decision
198d
Days
Class 2
Risk

K171014 is an FDA 510(k) clearance for the VICTUS Femtosecond Laser Platform. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Technolas Perfect Vision GmbH (München, DE). The FDA issued a Cleared decision on October 19, 2017 after a review of 198 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Technolas Perfect Vision GmbH devices

Submission Details

510(k) Number K171014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2017
Decision Date October 19, 2017
Days to Decision 198 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
88d slower than avg
Panel avg: 110d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOE Ophthalmic Femtosecond Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
Definition Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - OOE Ophthalmic Femtosecond Laser

All 17
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K171014.
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430 · Lensar, Inc. · Aug 2018
LenSx Laser System
K173660 · Alcon Laboratories, Inc. · Mar 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K173346 · Lensar, Inc. · Mar 2018
LenSx Laser System
K163551 · Alcon Laboratories, Inc. · Feb 2017
LenSX Laser System
K161288 · Alcon Laboratories, Inc. · Nov 2016