Cleared Traditional

K010114 - ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)

K010114 is an FDA 510(k) clearance for ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, manufactured by Johnson & Johnson Vision Care, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K010114 · Johnson & Johnson Vision Care, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
85d
Days
Class 2
Risk

K010114 is an FDA 510(k) clearance for the ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Johnson & Johnson Vision Care, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 11, 2001 after a review of 85 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.

View all Johnson & Johnson Vision Care, Inc. devices

FDA 510(k) Submission Details - K010114

510(k) Number K010114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date April 11, 2001
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
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 444
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K010114.
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)
K004049 · Optech, Inc. · May 2001
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C
K011089 · Specialty Ultravision, Inc. · May 2001
VISTAKON (METHAFILCON A) CONTACT LENSES
K010507 · Vistakon · Apr 2001
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL
K010256 · Opti-Centre Laboratories · Mar 2001
VISTAKON (HEFILCON C) CONTACT LENSES
K010218 · Vistakon · Mar 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
K010223 · American Contact Lens, Inc. · Mar 2001