Cleared Abbreviated

K020193 - OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

K020193 is an FDA 510(k) clearance for OCULAR SCIENCES, manufactured by Cl Mcintosh. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Abbreviated 510(k) pathway after a 41-day FDA review.

K020193 · Cl Mcintosh · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
41d
Days
Class 2
Risk

K020193 is an FDA 510(k) clearance for the OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) C.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Cl Mcintosh (Rockville, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 41 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K020193

510(k) Number K020193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2002
Decision Date February 28, 2002
Days to Decision 41 days
Submission Type Abbreviated
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
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Standards-based clearance path.

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 K020193.
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · CooperVision, Inc. · Apr 2002
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
K020690 · Ocu-Ease Optical Products, Inc. · Apr 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
K020139 · Ciba Vision Corporation · Apr 2002
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
K013973 · Vistakon · Feb 2002
OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
K013445 · Florida Optical Engineering, Inc. · Dec 2001
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
K013649 · Sauflon Pharmaceuticals, Ltd. · Dec 2001
K020193 · OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
Download PDF FDA Summary Cl Mcintosh