Cleared Traditional

K101285 - CONSTELLATION VISION SYSTEM

K101285 is an FDA 510(k) clearance for CONSTELLATION VISION SYSTEM, 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 189-day FDA review.

K101285 · Alcon Manufacturing, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
189d
Days
Class 2
Risk

K101285 is an FDA 510(k) clearance for the CONSTELLATION VISION SYSTEM. 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 12, 2010 after a review of 189 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 - K101285

510(k) Number K101285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2010
Decision Date November 12, 2010
Days to Decision 189 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
79d slower than avg
Panel avg: 110d · This submission: 189d
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 K101285.
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
STELLARIS PC VISION ENHANCEMENT SYSTEM
K101325 · Bausch & Lomb, Inc. · Aug 2010
AQUALASE CAPSULE WASH TIP
K093210 · Alcon Manufacturing, Ltd. · Mar 2010
FLUID ISOLATION DEVICE
K091915 · Lenstec, Inc. · Oct 2009
K101285 · CONSTELLATION VISION SYSTEM
Download PDF FDA Summary Alcon Manufacturing, …