Cleared Traditional

K954058 - BARRAQUER-KRUMEICH REFRACTIVE SET

K954058 is an FDA 510(k) clearance for BARRAQUER-KRUMEICH REFRACTIVE SET, manufactured by Eyetech M.V.A.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K954058

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.

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 59
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K954058.
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