Cleared Traditional

K923435 - CORNEAL TOPOGRAPHY SYSTEM

K923435 is the FDA 510(k) clearance for CORNEAL TOPOGRAPHY SYSTEM by Par Microsystems Corp.. It is a Class 1 Ophthalmic device (product code HLQ) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K923435 · Par Microsystems Corp. · Ophthalmic device
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Feb 1993
Decision
218d
Days
Class 1
Risk

K923435 is an FDA 510(k) clearance for the CORNEAL TOPOGRAPHY SYSTEM. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Par Microsystems Corp. (New Hartford, US). The FDA issued a Cleared decision on February 16, 1993 after a review of 218 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 Par Microsystems Corp. devices

Submission Details

510(k) Number K923435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date February 16, 1993
Days to Decision 218 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
108d slower than avg
Panel avg: 110d · This submission: 218d
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.

Regulatory Peers - HLQ Keratoscope, Ac-powered

All 7
Devices cleared under the same product code (HLQ) and FDA review panel - the closest regulatory comparables to K923435.
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
ZEISS OPERATING KERATOMETER
K853723 · Carl Zeiss, Inc. · Oct 1985