Cleared Traditional

K151161 - VICTUS Femtosecond Laser Platform

K151161 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 54-day FDA review.

K151161 · Technolas Perfect Vision GmbH · Ophthalmic device
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Jun 2015
Decision
54d
Days
Class 2
Risk

K151161 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 June 24, 2015 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Technolas Perfect Vision GmbH devices

Submission Details

510(k) Number K151161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date June 24, 2015
Days to Decision 54 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
56d faster than avg
Panel avg: 110d · This submission: 54d
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.