Cleared Traditional

K101626 - LENSX LASER SYSTEM

K101626 is an FDA 510(k) clearance for LENSX LASER SYSTEM, manufactured by Lensx Lasers, Inc.. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K101626 · Lensx Lasers, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
131d
Days
Class 2
Risk

K101626 is an FDA 510(k) clearance for the LENSX LASER SYSTEM. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Lensx Lasers, Inc. (Laguna Beach, US). The FDA issued a Cleared decision on October 18, 2010 after a review of 131 days - within the typical 510(k) review window.

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 - K101626

510(k) Number K101626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2010
Decision Date October 18, 2010
Days to Decision 131 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
21d slower than avg
Panel avg: 110d · This submission: 131d
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 K101626.
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
K110427 · Technolas Perfect Vision GmbH · Nov 2011
TBD
K112098 · Lensar, Inc. · Oct 2011
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
K102727 · Lensar, Inc. · Mar 2011
LENSAR LASER SYSTEM
K090633 · Lensar, Inc. · May 2010
LENSX 550 LASER SYSTEM. MODEL 550
K094052 · Lensx Lasers, Inc. · Apr 2010
LENSX 550 LASER SYSTEM
K092647 · Lensx Lasers, Inc. · Dec 2009
K101626 · LENSX LASER SYSTEM
Download PDF FDA Summary Lensx Lasers, Inc.