Cleared Traditional

EPIVISION SL SYSTEM (K072102) - FDA 510(k) Clearance

Class I Ophthalmic device.

K072102 · Gebauer Medizintechnik GmbH · Ophthalmic device
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Jan 2009
Decision
535d
Days
Class 1
Risk

K072102 is an FDA 510(k) clearance for the EPIVISION SL SYSTEM. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Gebauer Medizintechnik GmbH (Lexington, US). The FDA issued a Cleared decision on January 16, 2009 after a review of 535 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

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Submission Details

510(k) Number K072102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2007
Decision Date January 16, 2009
Days to Decision 535 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
425d slower than avg
Panel avg: 110d · This submission: 535d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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.