Cleared Traditional

K890687 - ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER

K890687 is an FDA 510(k) clearance for ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER, manufactured by Optimed, Inc.. The device is a Class 1 Ophthalmic device with product code HLQ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K890687 · Optimed, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K890687

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.

HLQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - HLQ Keratoscope, Ac-powered

All 11
Devices cleared under the same product code (HLQ) and FDA review panel - the closest regulatory comparables to K890687.
EYECHEK
K964290 · Reichert Ophthalmic Instruments, Div. Leica, Inc. · Jan 1997
TBD KERATOSCOPE
K912130 · Alcon Laboratories · Aug 1991
CANON AUTO REF-KERATOMETER RK-2
K895475 · Canon USA, Inc. · Oct 1989
CANON SURGICAL AUTO KERATOMETER SK-1
K871936 · Canon USA, Inc. · Jun 1987
NIDEK KM-1000 SURGICAL KERATOMETER
K862137 · Nidek, Inc. · Jul 1986
NIDEK KM-800 AUTO KERATOMETER
K861063 · Nidek, Inc. · Apr 1986