Cleared Traditional

K120732 - LENSSX LASER SYSTEM

K120732 is an FDA 510(k) clearance for LENSSX LASER SYSTEM, manufactured by Alcon Lensx, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K120732 · Alcon Lensx, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
181d
Days
Class 2
Risk

K120732 is an FDA 510(k) clearance for the LENSSX LASER SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Lensx, Inc. (Laguna Beach, US). The FDA issued a Cleared decision on September 6, 2012 after a review of 181 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 - K120732

510(k) Number K120732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2012
Decision Date September 06, 2012
Days to Decision 181 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
71d slower than avg
Panel avg: 110d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 260
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K120732.
CENTURION VISION SYSTEM
K121555 · Alcon Laboratories, Inc. · Dec 2012
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
K122829 · Lensar, Inc. · Dec 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K121721 · Abbott Medical Optics, Inc. · Oct 2012
INFINITI(R) VISION SYSTEM
K120912 · Alcon Manufacturing, Ltd. · Jun 2012
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
K111446 · Abbott Medical Optics, Inc. · Dec 2011
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
K112425 · Alcon Manufacturing, Ltd. · Nov 2011
K120732 · LENSSX LASER SYSTEM
Download PDF FDA Summary Alcon Lensx, Inc.