Cleared Traditional

K123120 - LENSX LASER SYSTEM

K123120 is an FDA 510(k) clearance for LENSX LASER SYSTEM, manufactured by Alcon Lensx, Inc.. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K123120 · Alcon Lensx, Inc. · Ophthalmic device
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Dec 2012
Decision
70d
Days
Class 2
Risk

K123120 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 Lensx, Inc. (Laguna Beach, US). The FDA issued a Cleared decision on December 12, 2012 after a review of 70 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 Alcon Lensx, Inc. devices

FDA 510(k) Submission Details - K123120

510(k) Number K123120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2012
Decision Date December 12, 2012
Days to Decision 70 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
40d faster than avg
Panel avg: 110d · This submission: 70d
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.