Cleared Traditional

K052560 - BIOFINITY (COMFILCON A) SOFT CONTACT LENS

K052560 is an FDA 510(k) clearance for BIOFINITY (COMFILCON A) SOFT CONTACT LENS, manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K052560 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
81d
Days
Class 2
Risk

K052560 is an FDA 510(k) clearance for the BIOFINITY (COMFILCON A) SOFT CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 6, 2005 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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.

FDA 510(k) Submission Details - K052560

510(k) Number K052560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date December 06, 2005
Days to Decision 81 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
29d faster than avg
Panel avg: 110d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 - LPL Lenses, Soft Contact, Daily Wear

All 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K052560.
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS
K052290 · Clearlab Pte , Ltd. · May 2006
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
K051477 · Mi Gwang Contact Lens Co., Ltd. · Mar 2006
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
K052606 · Marietta Vision · Dec 2005
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
K052703 · Alden Optical Labs., Inc. · Nov 2005
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051095 · Optical Connection, Inc. · Aug 2005
DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051129 · Innova Vision, Inc. · Aug 2005
K052560 · BIOFINITY (COMFILCON A) SOFT CONTACT LENS
Download PDF FDA Summary CooperVision, Inc.