Cleared Traditional

K965052 - D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES

K965052 is an FDA 510(k) clearance for D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYD..., manufactured by Wesley Jessen Corp.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K965052 · Wesley Jessen Corp. · Ophthalmic device
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May 1997
Decision
147d
Days
Class 2
Risk

K965052 is an FDA 510(k) clearance for the D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Wesley Jessen Corp. (Des Plaines, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Wesley Jessen Corp. devices

FDA 510(k) Submission Details - K965052

510(k) Number K965052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date May 14, 1997
Days to Decision 147 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
37d slower than avg
Panel avg: 110d · This submission: 147d
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 357
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K965052.
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
K971049 · Aspect Vision Care, Ltd. · May 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K971164 · Aspect Vision Care, Ltd. · May 1997
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)
K971515 · Biomed Devices Corp. · May 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · Ciba Vision Corporation · May 1997
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
K970095 · Biocompatibles Eyewear, Inc. · Apr 1997
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
K970312 · Flexlens, Inc. · Apr 1997