Cleared Traditional

K930446 - MARCO TRIAL SETS

K930446 is an FDA 510(k) clearance for MARCO TRIAL SETS, manufactured by Marco Ophthalmic, Inc.. The device is a Class 1 Ophthalmic device with product code HPC cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K930446 · Marco Ophthalmic, Inc. · Ophthalmic device
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Jul 1993
Decision
161d
Days
Class 1
Risk

K930446 is an FDA 510(k) clearance for the MARCO TRIAL SETS. Classified as Set, Lens, Trial, Ophthalmic (product code HPC), Class I - General Controls.

Submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 6, 1993 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1405 - 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 - K930446

510(k) Number K930446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date July 06, 1993
Days to Decision 161 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
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

HPC Device Classification - Class 1, General Controls

Product Code HPC Set, Lens, Trial, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1405
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.

Regulatory Peers - HPC Set, Lens, Trial, Ophthalmic

Devices cleared under the same product code (HPC) and FDA review panel - the closest regulatory comparables to K930446.
BURTON TRIAL LENS SET
K924786 · R.H. Burton Co. · Apr 1993
TRIAL LENS SET
K920571 · R.H. Burton Co. · May 1992
WOODLYN FULL APERTURE TRIAL LENS SET
K900478 · Woodlyn, Inc. · Feb 1990
WOODLYN CLASSIC TRIAL LENS SET
K841766 · Woodlyn, Inc. · Jun 1984
LENS SET, MENTOR TRIAL
K770389 · Codman & Shurtleff, Inc. · Mar 1977