Cleared Traditional

AUTOMATIC LENSOMETER

K936199 · Canon USA, Inc. · Ophthalmic
Sep 1994
Decision
273d
Days
Class 1
Risk

About This 510(k) Submission

K936199 is an FDA 510(k) clearance for the AUTOMATIC LENSOMETER, a Instrument, Measuring, Lens, Ac-powered (Class I — General Controls, product code HLM), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on September 28, 1994, 273 days after receiving the submission on December 29, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1425.

Submission Details

510(k) Number K936199 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1993
Decision Date September 28, 1994
Days to Decision 273 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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