Cleared Traditional

OPTEC 3000 (K924741) - FDA 510(k) Clearance

Class I Ophthalmic device.

K924741 · Stereo Optical Co., Inc. · Ophthalmic device
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Apr 1993
Decision
196d
Days
Class 1
Risk

K924741 is an FDA 510(k) clearance for the OPTEC 3000. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Stereo Optical Co., Inc. (Chicago, US). The FDA issued a Cleared decision on April 6, 1993 after a review of 196 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - 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 Stereo Optical Co., Inc. devices

Submission Details

510(k) Number K924741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1992
Decision Date April 06, 1993
Days to Decision 196 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
86d slower than avg
Panel avg: 110d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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.