Cleared Traditional

K112425 - INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE

K112425 is an FDA 510(k) clearance for INFINITI VISION SYSTEM EVERGREEN II AUT..., manufactured by Alcon Manufacturing, Ltd.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K112425 · Alcon Manufacturing, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
90d
Days
Class 2
Risk

K112425 is an FDA 510(k) clearance for the INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Manufacturing, Ltd. (Irvine, US). The FDA issued a Cleared decision on November 21, 2011 after a review of 90 days - within the typical 510(k) review window.

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 - K112425

510(k) Number K112425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2011
Decision Date November 21, 2011
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K112425.
LENSSX LASER SYSTEM
K120732 · Alcon Lensx, Inc. · Sep 2012
INFINITI(R) VISION SYSTEM
K120912 · Alcon Manufacturing, Ltd. · Jun 2012
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
K111446 · Abbott Medical Optics, Inc. · Dec 2011
LAMINAR FLOW PHACO TIPS
K111882 · Abbott Medical Optics, Inc. · Nov 2011
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
K111697 · Abbott Medical Optics, Inc. · Sep 2011
UNIT, PHACOFRAGMENTATION
K103023 · Abbott Medical Optics, Inc. · Jun 2011
K112425 · INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
Download PDF FDA Summary Alcon Manufacturing, …