Cleared Traditional

K900478 - WOODLYN FULL APERTURE TRIAL LENS SET

K900478 is an FDA 510(k) clearance for WOODLYN FULL APERTURE TRIAL LENS SET, manufactured by Woodlyn, Inc.. The device is a Class 1 Ophthalmic device with product code HPC cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K900478 · Woodlyn, Inc. · Ophthalmic device
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Feb 1990
Decision
20d
Days
Class 1
Risk

K900478 is an FDA 510(k) clearance for the WOODLYN FULL APERTURE TRIAL LENS SET. Classified as Set, Lens, Trial, Ophthalmic (product code HPC), Class I - General Controls.

Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on February 21, 1990 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1405 - 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 Woodlyn, Inc. devices

FDA 510(k) Submission Details - K900478

510(k) Number K900478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1990
Decision Date February 21, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

HPC Device Classification - Class 1, General Controls

Product Code HPC Set, Lens, Trial, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1405
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.