Cleared Traditional

EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (K964702) - FDA 510(k) Clearance

Class I Ophthalmic device.

K964702 · Euclid Systems Corp. · Ophthalmic device
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May 1997
Decision
176d
Days
Class 1
Risk

K964702 is an FDA 510(k) clearance for the EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800. Classified as Topographer, Corneal, Ac-powered (product code MMQ), Class I - General Controls.

Submitted by Euclid Systems Corp. (West Cadwell, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 176 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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 Euclid Systems Corp. devices

Submission Details

510(k) Number K964702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date May 20, 1997
Days to Decision 176 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
66d slower than avg
Panel avg: 110d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMQ Topographer, Corneal, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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.