Cleared Traditional

K946012 - PRECISION UV(TM) (VASURFICON A)

K946012 is an FDA 510(k) clearance for PRECISION UV(TM) (VASURFICON A), manufactured by Pilkington Barnes-Hind, Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K946012 · Pilkington Barnes-Hind, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
43d
Days
Class 2
Risk

K946012 is an FDA 510(k) clearance for the PRECISION UV(TM) (VASURFICON A). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Pilkington Barnes-Hind, Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 43 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 - K946012

510(k) Number K946012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date January 24, 1995
Days to Decision 43 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
67d faster than avg
Panel avg: 110d · This submission: 43d
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 K946012.
HORIZON 55 BI-CON TORIC
K950818 · Westcon Contact Lens Co., Inc. · Mar 1995
LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS
K945981 · Permeable Technologies, Inc. · Feb 1995
LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS
K950283 · Permeable Technologies, Inc. · Feb 1995
HORIZON 55 BI-CON
K945365 · Westcon Contact Lens Co., Inc. · Dec 1994
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · Bausch & Lomb, Inc. · Dec 1994
OCU-FLEX-38 (POLYMACON)
K941998 · Ocu-Ease Optical Products, Inc. · Oct 1994
K946012 · PRECISION UV(TM) (VASURFICON A)
Download PDF FDA Summary Pilkington Barnes-Hin…