Cleared Traditional

K920861 - WOODLYN CLASSIC LENSMETER

K920861 is the FDA 510(k) clearance for WOODLYN CLASSIC LENSMETER by Woodlyn, Inc.. It is a Class 1 Ophthalmic device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 110d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (HLM) and FDA review panel - the closest regulatory comparables to K920861.
AUTOMATIC LENSOMETER
K936199 · Canon USA, Inc. · Sep 1994
NIDEK LM-870 AUTOMATIC LENSMETER
K884188 · Nidek, Inc. · Nov 1988
BAUSCH & LOMB VERTOMETER V-5
K862518 · Bausch & Lomb, Inc. · Aug 1986
LM-850 AUTOMATIC LENSMETER
K861064 · Nidek, Inc. · Apr 1986
VERI-VU LENSOMETER
K791521 · Intermedics, Inc. · Oct 1979