Cleared Traditional

K991163 - VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR

K991163 is an FDA 510(k) clearance for VISTAKON (LENEFILCON A) SOFT (HYDROPHIL..., 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 62-day FDA review.

K991163 · 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
Jun 1999
Decision
62d
Days
Class 2
Risk

K991163 is an FDA 510(k) clearance for the VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILI.... 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 June 8, 1999 after a review of 62 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 - K991163

510(k) Number K991163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date June 08, 1999
Days to Decision 62 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
48d faster than avg
Panel avg: 110d · This submission: 62d
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
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K991163 · VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
Download PDF FDA Summary Vistakon, Johnson & J…