Cleared Traditional

K920861 - WOODLYN CLASSIC LENSMETER
(FDA 510(k) Clearance)

K920861 · Woodlyn, Inc. · Ophthalmic device

Jul 1992

Decision

156d

Days

Class 1

Risk

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

Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on July 30, 1992, 156 days after receiving the submission on February 25, 1992.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1425.

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