Cleared Traditional

K993935 - DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI

K993935 is an FDA 510(k) clearance for DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TO..., 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 32-day FDA review.

K993935 · Wesley Jessen Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
32d
Days
Class 2
Risk

K993935 is an FDA 510(k) clearance for the DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURA.... 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 December 21, 1999 after a review of 32 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.

View all Wesley Jessen Corp. devices

FDA 510(k) Submission Details - K993935

510(k) Number K993935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1999
Decision Date December 21, 1999
Days to Decision 32 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
78d faster than avg
Panel avg: 110d · This submission: 32d
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 K993935.
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
K994318 · Vistakon, Johnson & Johnson Vision Products, Inc. · Feb 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
ACTIFRESH 400 LENS
K983637 · Hydron , Ltd. · Dec 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K992264 · Ocular Sciences Puerto Rico, Inc. · Nov 1999
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
K992950 · Prosthetic Soft Lens Corp. · Nov 1999