Cleared Traditional

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (K944207) - FDA 510(k) Clearance

Class I Ophthalmic device.

K944207 · Computed Anatomy, Inc. · Ophthalmic device
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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

Submission Details

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.

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.