Cleared Traditional

K091339 - BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

K091339 is an FDA 510(k) clearance for BIOMEDICS (OCUFILCON D) SOFT (HYDROPHIL..., manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K091339 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
244d
Days
Class 2
Risk

K091339 is an FDA 510(k) clearance for the BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Norfolk, US). The FDA issued a Cleared decision on January 5, 2010 after a review of 244 days - an extended review 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: 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.

FDA 510(k) Submission Details - K091339

510(k) Number K091339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2009
Decision Date January 05, 2010
Days to Decision 244 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
134d slower than avg
Panel avg: 110d · This submission: 244d
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 K091339.
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
K091327 · Alden Optical Labs., Inc. · Jun 2010
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
K100349 · Johnson & Johnson Vision Care, Inc. · May 2010
SAVIEW 58 UV
K092852 · St. shine Optical Co., Ltd. · Mar 2010
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
K090806 · Safilens, S.R.L. · Dec 2009
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
K083288 · Innova Vision, Inc. · Sep 2009
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K082879 · I-See Vision Technology, Inc. · Jun 2009
K091339 · BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
Download PDF FDA Summary CooperVision, Inc.