Cleared Traditional

K932258 - OPTICOM M600 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K932258 · Clement Clarke, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
441d
Days
Class 1
Risk

K932258 is an FDA 510(k) clearance for the OPTICOM M600. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Clement Clarke, Inc. (Columbus, US). The FDA issued a Cleared decision on July 25, 1994 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Clement Clarke, Inc. devices

Submission Details

510(k) Number K932258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1993
Decision Date July 25, 1994
Days to Decision 441 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
331d slower than avg
Panel avg: 110d · This submission: 441d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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.