Cleared Traditional

K120426 - VICTUS LASER PLATFORM

K120426 is the FDA 510(k) clearance for VICTUS 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 169-day FDA review.

K120426 · Technolas Perfect Vision GmbH · Ophthalmic device
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Jul 2012
Decision
169d
Days
Class 2
Risk

K120426 is an FDA 510(k) clearance for the VICTUS LASER PLATFORM. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Technolas Perfect Vision GmbH (San Francisco, US). The FDA issued a Cleared decision on July 31, 2012 after a review of 169 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 K120426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2012
Decision Date July 31, 2012
Days to Decision 169 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
59d slower than avg
Panel avg: 110d · This submission: 169d
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.