Cleared Traditional

CARRIAZO-PENDULAR MICROKERATOME (K082043) - FDA 510(k) Clearance

Class I Ophthalmic device.

K082043 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Ophthalmic device
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Aug 2008
Decision
14d
Days
Class 1
Risk

K082043 is an FDA 510(k) clearance for the CARRIAZO-PENDULAR MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Schwind Eye-Tech-Solutions GmbH & Co. KG (Kleinostheim, DE). The FDA issued a Cleared decision on August 1, 2008 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Schwind Eye-Tech-Solutions GmbH & Co. KG devices

Submission Details

510(k) Number K082043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2008
Decision Date August 01, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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.