Cleared Traditional

ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER (K890687) - FDA 510(k) Clearance

Class I Ophthalmic device.

K890687 · Optimed, Inc. · Ophthalmic device
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Sep 1989
Decision
208d
Days
Class 1
Risk

K890687 is an FDA 510(k) clearance for the ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Optimed, Inc. (Oakland, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 208 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 Optimed, Inc. devices

Submission Details

510(k) Number K890687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1989
Decision Date September 05, 1989
Days to Decision 208 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 110d · This submission: 208d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLQ Keratoscope, 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.