Cleared Traditional

BARRAQUER-KRUMEICH REFRACTIVE SET (K954058) - FDA 510(k) Clearance

Class I Ophthalmic device.

K954058 · Eyetech M.V.A. · Ophthalmic device
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Nov 1995
Decision
154d
Days
Class 1
Risk

K954058 is an FDA 510(k) clearance for the BARRAQUER-KRUMEICH REFRACTIVE SET. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Eyetech M.V.A. (Fl-9496 Balzers, Liechtenstein, DE). The FDA issued a Cleared decision on November 6, 1995 after a review of 154 days - an extended review cycle.

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.

View all Eyetech M.V.A. devices

Submission Details

510(k) Number K954058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date November 06, 1995
Days to Decision 154 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 110d · This submission: 154d
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.