Cleared Traditional

BURTON LENSMETER

K924788 · R.H. Burton Co. · Ophthalmic
Apr 1993
Decision
194d
Days
Class 1
Risk

About This 510(k) Submission

K924788 is an FDA 510(k) clearance for the BURTON LENSMETER, a Instrument, Measuring, Lens, Ac-powered (Class I — General Controls, product code HLM), submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 5, 1993, 194 days after receiving the submission on September 23, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1425.

Submission Details

510(k) Number K924788 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1992
Decision Date April 05, 1993
Days to Decision 194 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