Cleared Traditional

K964702 - EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800

K964702 is an FDA 510(k) clearance for EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODE..., manufactured by Euclid Systems Corp.. The device is a Class 1 Ophthalmic device with product code MMQ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

FDA 510(k) Submission Details - K964702

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 110d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

MMQ Device Classification - Class 1, General Controls

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.