Cleared Traditional

K944207 - TOPOGRAPHIC MODELING SYSTEM 2 TMS-2

K944207 is an FDA 510(k) clearance for TOPOGRAPHIC MODELING SYSTEM 2 TMS-2, manufactured by Computed Anatomy, Inc.. The device is a Class 1 Ophthalmic device with product code HLQ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K944207 · Computed Anatomy, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
100d
Days
Class 1
Risk

K944207 is an FDA 510(k) clearance for the TOPOGRAPHIC MODELING SYSTEM 2 TMS-2. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Computed Anatomy, Inc. (New York, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 100 days - within the typical 510(k) review window.

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 Computed Anatomy, Inc. devices

FDA 510(k) Submission Details - K944207

510(k) Number K944207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1994
Decision Date December 07, 1994
Days to Decision 100 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 110d · This submission: 100d
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 K944207.
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
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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