Cleared Traditional

K962804 - ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER

K962804 is an FDA 510(k) clearance for ACUVUE (ETAFILCON A) CONTACT LENS CLEAR..., manufactured by Vistakon, Johnson & Johnson Vision Products, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K962804 · Vistakon, Johnson & Johnson Vision Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
75d
Days
Class 2
Risk

K962804 is an FDA 510(k) clearance for the ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Vistakon, Johnson & Johnson Vision Products, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 1, 1996 after a review of 75 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 - K962804

510(k) Number K962804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date October 01, 1996
Days to Decision 75 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
35d faster than avg
Panel avg: 110d · This submission: 75d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K962804.
PRECISION UV (VASURFILCON A)
K961299 · Pilkington Barnes-Hind, Ltd. · Oct 1996
FLEXLENS
K961943 · Flexlens, Inc. · Oct 1996
FLEXLENS(METHAFILCON A)
K962000 · Flexlens, Inc. · Oct 1996
RURASOFT 2 FRESHLOOK COLORS
K962957 · Wesley Jessen Corp. · Oct 1996
GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K962710 · Gelflex Laboratories · Sep 1996
GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
K962711 · Gelflex Laboratories · Sep 1996
K962804 · ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER
Download PDF FDA Summary Vistakon, Johnson & J…