Cleared Traditional

K141065 - CONSTELLATION VISION SYSTEM

K141065 is an FDA 510(k) clearance for CONSTELLATION VISION SYSTEM, manufactured by Alcon Research, Ltd.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K141065 · Alcon Research, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
120d
Days
Class 2
Risk

K141065 is an FDA 510(k) clearance for the CONSTELLATION VISION SYSTEM. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Alcon Research, Ltd. (Lake Forest, US). The FDA issued a Cleared decision on August 22, 2014 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 Research, Ltd. devices

FDA 510(k) Submission Details - K141065

510(k) Number K141065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2014
Decision Date August 22, 2014
Days to Decision 120 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
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 92
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K141065.
UniVit HE, UniVit UHS
K212763 · Visioncare Devices, LLC · Aug 2022
Cetus system, Cetus probe
K170183 · A.R.C Laser GmbH · Sep 2017
Bi-Blade Vitrectomy Cutter
K153168 · Medical Instrument Development Laboratories · Apr 2016
VERSAVIT
K121675 · Synergetics, Inc. · Jun 2012
PROCARE PLUS VITRECTOMY SYSTEM
K120170 · Visioncare Devices, Inc. · May 2012
ULTIMATE VIT ENHAMCER (UVE)
K102222 · Medical Instrument Development Laboratories, Inc. · Apr 2011