Cleared Traditional

CARRIAZO PENDULAR (K032910) - FDA 510(k) Clearance

Class I Ophthalmic device.

K032910 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Ophthalmic device
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Aug 2004
Decision
343d
Days
Class 1
Risk

K032910 is an FDA 510(k) clearance for the CARRIAZO PENDULAR. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Schwind Eye-Tech-Solutions GmbH & Co. KG (Coto De Caza, US). The FDA issued a Cleared decision on August 30, 2004 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Schwind Eye-Tech-Solutions GmbH & Co. KG devices

Submission Details

510(k) Number K032910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date August 30, 2004
Days to Decision 343 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 110d · This submission: 343d
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.