Cleared Traditional

K082043 - CARRIAZO-PENDULAR MICROKERATOME

K082043 is an FDA 510(k) clearance for CARRIAZO-PENDULAR MICROKERATOME, manufactured by Schwind Eye-Tech-Solutions GmbH & Co. KG. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K082043 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K082043

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HNO Keratome, Ac-powered

All 82
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K082043 · CARRIAZO-PENDULAR MICROKERATOME
Download PDF FDA Summary Schwind Eye-Tech-Solu…