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)
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.

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

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
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 Peers - HNO Keratome, Ac-powered

All 43
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