Cleared Traditional

EH-270 CORNEAL TOPOGRAPHER (K933556) - FDA 510(k) Clearance

Class I Ophthalmic device.

K933556 · Visioptic, Inc. · Ophthalmic device
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Nov 1993
Decision
104d
Days
Class 1
Risk

K933556 is an FDA 510(k) clearance for the EH-270 CORNEAL TOPOGRAPHER. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Visioptic, Inc. (Houston, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 104 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 Visioptic, Inc. devices

Submission Details

510(k) Number K933556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1993
Decision Date November 02, 1993
Days to Decision 104 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
6d faster than avg
Panel avg: 110d · This submission: 104d
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.