Cleared Traditional

K963762 - CORNEAL TOPOGRAPHER 200

K963762 is an FDA 510(k) clearance for CORNEAL TOPOGRAPHER 200, manufactured by Eclipse Ventures. The device is a Class 1 Ophthalmic device with product code MMQ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K963762 · Eclipse Ventures · Ophthalmic device
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Dec 1996
Decision
95d
Days
Class 1
Risk

K963762 is an FDA 510(k) clearance for the CORNEAL TOPOGRAPHER 200. Classified as Topographer, Corneal, Ac-powered (product code MMQ), Class I - General Controls.

Submitted by Eclipse Ventures (Princeton, US). The FDA issued a Cleared decision on December 23, 1996 after a review of 95 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 Eclipse Ventures devices

FDA 510(k) Submission Details - K963762

510(k) Number K963762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1996
Decision Date December 23, 1996
Days to Decision 95 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 110d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

MMQ Device Classification - Class 1, General Controls

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.