Cleared Abbreviated

HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS (K031477) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K031477 · Ocular Sciences, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
70d
Days
Class 2
Risk

K031477 is an FDA 510(k) clearance for the HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Ocular Sciences, Inc. (Rockville, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 70 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.

View all Ocular Sciences, Inc. devices

Submission Details

510(k) Number K031477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2003
Decision Date July 18, 2003
Days to Decision 70 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 485
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