Cleared Traditional

K930448 - MARCO PROJECTION PERIMETER

K930448 is an FDA 510(k) clearance for MARCO PROJECTION PERIMETER, manufactured by Marco Ophthalmic, Inc.. The device is a Class 1 Ophthalmic device with product code HOO cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K930448 · Marco Ophthalmic, Inc. · Ophthalmic device
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Jun 1993
Decision
146d
Days
Class 1
Risk

K930448 is an FDA 510(k) clearance for the MARCO PROJECTION PERIMETER. Classified as Perimeter, Ac-powered (product code HOO), 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 886.1605 - 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: 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

FDA 510(k) Submission Details - K930448

510(k) Number K930448 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.

HOO Device Classification - Class 1, General Controls

Product Code HOO Perimeter, 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.