Cleared Traditional

INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (K950077) - FDA 510(k) Clearance

Class I Ophthalmic device.

K950077 · Par Vision Systems Corp. · Ophthalmic device
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Jun 1995
Decision
155d
Days
Class 1
Risk

K950077 is an FDA 510(k) clearance for the INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS). Classified as Topographer, Corneal, Ac-powered (product code MMQ), Class I - General Controls.

Submitted by Par Vision Systems Corp. (New Hartford, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 155 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 Vision Systems Corp. devices

Submission Details

510(k) Number K950077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date June 14, 1995
Days to Decision 155 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
45d slower than avg
Panel avg: 110d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMQ Topographer, Corneal, 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.