Cleared Traditional

K944616 - KERATRON CORNEAL TOPOGRAPHER

K944616 is an FDA 510(k) clearance for KERATRON CORNEAL TOPOGRAPHER, manufactured by Alliance Medical Marketinig. The device is a Class 1 Ophthalmic device with product code HLQ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K944616 · Alliance Medical Marketinig · Ophthalmic device
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Nov 1994
Decision
63d
Days
Class 1
Risk

K944616 is an FDA 510(k) clearance for the KERATRON CORNEAL TOPOGRAPHER. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Alliance Medical Marketinig (Jacksonville Beach, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alliance Medical Marketinig devices

FDA 510(k) Submission Details - K944616

510(k) Number K944616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1994
Decision Date November 22, 1994
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
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 K944616.
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299 · Nidek Co., Ltd. · Mar 2001
EYE SYS VISTA
K973756 · Eyesys Technologies, Inc. · Nov 1997
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