Cleared Traditional

MARCO LM-770 DIGITAL PROJECTION LENSMETER

K930445 · Marco Ophthalmic, Inc. · Ophthalmic

Jun 1993

Decision

146d

Days

Class 1

Risk

About This 510(k) Submission

K930445 is an FDA 510(k) clearance for the MARCO LM-770 DIGITAL PROJECTION LENSMETER, a Instrument, Measuring, Lens, Ac-powered (Class I — General Controls, product code HLM), submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 21, 1993, 146 days after receiving the submission on January 26, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1425.

Submission Details

510(k) Number	K930445 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1993
Decision Date	June 21, 1993
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement