Cleared Traditional

K920861 - WOODLYN CLASSIC LENSMETER

K920861 is an FDA 510(k) clearance for WOODLYN CLASSIC LENSMETER, manufactured by Woodlyn, Inc.. The device is a Class 1 Ophthalmic device with product code HLM cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K920861 · Woodlyn, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
156d
Days
Class 1
Risk

K920861 is an FDA 510(k) clearance for the WOODLYN CLASSIC LENSMETER. Classified as Instrument, Measuring, Lens, Ac-powered (product code HLM), Class I - General Controls.

Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 156 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1425 - 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 Woodlyn, Inc. devices

FDA 510(k) Submission Details - K920861

510(k) Number K920861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date July 30, 1992
Days to Decision 156 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
46d slower than avg
Panel avg: 110d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

HLM Device Classification - Class 1, General Controls

Product Code HLM Instrument, Measuring, Lens, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1425
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.

Regulatory Peers - HLM Instrument, Measuring, Lens, Ac-powered

All 8
Devices cleared under the same product code (HLM) and FDA review panel - the closest regulatory comparables to K920861.
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K861064 · Nidek, Inc. · Apr 1986