Cleared Traditional

K994318 - VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

K994318 is an FDA 510(k) clearance for VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC..., 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 63-day FDA review.

K994318 · 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
Feb 2000
Decision
63d
Days
Class 2
Risk

K994318 is an FDA 510(k) clearance for the VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TIN.... 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 February 23, 2000 after a review of 63 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 - K994318

510(k) Number K994318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date February 23, 2000
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
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 K994318.
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
K994335 · Wesley Jessen Corp. · Mar 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · CooperVision, Inc. · Mar 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
K994125 · Bausch & Lomb, Inc. · Mar 2000
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
K994324 · Vistakon, Johnson & Johnson Vision Products, Inc. · Feb 2000
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K993580 · Specialty Ultravision, Inc. · Feb 2000
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI
K993935 · Wesley Jessen Corp. · Dec 1999
K994318 · VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Download PDF FDA Summary Vistakon, Johnson & J…