Cleared Traditional

K041206 - EPITOME SYSTEM

K041206 is an FDA 510(k) clearance for EPITOME SYSTEM, manufactured by Gebauer Medizintechnik GmbH. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K041206 · Gebauer Medizintechnik GmbH · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
131d
Days
Class 1
Risk

K041206 is an FDA 510(k) clearance for the EPITOME 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 September 15, 2004 after a review of 131 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K041206

510(k) Number K041206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2004
Decision Date September 15, 2004
Days to Decision 131 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 110d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HNO Keratome, Ac-powered

All 82
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K041206.
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083 · Biovision AG · Nov 2004
CENTURION SES EPIKERATOME
K042810 · Norwood Abbey , Ltd. · Oct 2004
MB 105 MILLENNIUM BLADES
K041110 · Millennium Biomedical, Inc. · Oct 2004
CARRIAZO PENDULAR
K032910 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Aug 2004
M3 MICROKERATOME
K032836 · Moria SA · Jun 2004
M2 COMPATIBLE MICROKERATOME BLADE
K033457 · Micro Specialties, Inc. · May 2004
K041206 · EPITOME SYSTEM
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