Cleared Traditional

BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K020389) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020389 · Ocular Sciences · Ophthalmic device
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Jun 2002
Decision
119d
Days
Class 2
Risk

K020389 is an FDA 510(k) clearance for the BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS. Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Ocular Sciences (Rockville, US). The FDA issued a Cleared decision on June 4, 2002 after a review of 119 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 Ocular Sciences devices

Submission Details

510(k) Number K020389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2002
Decision Date June 04, 2002
Days to Decision 119 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 110d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVN Lens, Contact, (disposable)
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 - MVN Lens, Contact, (disposable)

All 24
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K020389.
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448 · Alcon Laboratories, Inc. · Sep 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202036 · Alcon Laboratories, Inc. · Aug 2020