Cleared Traditional

K161288 - LenSX Laser System

K161288 is the FDA 510(k) clearance for LenSX Laser System by Alcon Laboratories, Inc.. It is a Class 2 Ophthalmic device (product code OOE) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K161288 · Alcon Laboratories, Inc. · Ophthalmic device
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Nov 2016
Decision
191d
Days
Class 2
Risk

K161288 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 Alcon Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on November 16, 2016 after a review of 191 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 Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K161288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2016
Decision Date November 16, 2016
Days to Decision 191 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
81d slower than avg
Panel avg: 110d · This submission: 191d
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.