Cleared Traditional

K110427 - FEMTEC LASER SYSTEM FOR CAPSULOTOMY

K110427 is an FDA 510(k) clearance for FEMTEC LASER SYSTEM FOR CAPSULOTOMY, manufactured by Technolas Perfect Vision GmbH. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K110427 · Technolas Perfect Vision GmbH · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
281d
Days
Class 2
Risk

K110427 is an FDA 510(k) clearance for the FEMTEC LASER SYSTEM FOR CAPSULOTOMY. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Technolas Perfect Vision GmbH (Anaheim Hills, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 281 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.

FDA 510(k) Submission Details - K110427

510(k) Number K110427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date November 22, 2011
Days to Decision 281 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
171d slower than avg
Panel avg: 110d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OOE Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K110427.
VICTUS LASER PLATFORM
K120426 · Technolas Perfect Vision GmbH · Jul 2012
TBD
K120214 · Lensar, Inc. · Jun 2012
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K113479 · Optimedica Corporation · Dec 2011
TBD
K112098 · Lensar, Inc. · Oct 2011
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
K102727 · Lensar, Inc. · Mar 2011
LENSX LASER SYSTEM
K101626 · Lensx Lasers, Inc. · Oct 2010
K110427 · FEMTEC LASER SYSTEM FOR CAPSULOTOMY
Download PDF FDA Summary Technolas Perfect Vis…