Cleared Traditional

MARCO LM-770 DIGITAL PROJECTION LENSMETER (K930445) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930445 · Marco Ophthalmic, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
146d
Days
Class 1
Risk

K930445 is an FDA 510(k) clearance for the MARCO LM-770 DIGITAL PROJECTION LENSMETER. Classified as Instrument, Measuring, Lens, Ac-powered (product code HLM), Class I - General Controls.

Submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 21, 1993 after a review of 146 days - within the typical 510(k) review window.

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 Marco Ophthalmic, Inc. devices

Submission Details

510(k) Number K930445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 110d · This submission: 146d
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.