Cleared Traditional

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

K082043 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Ophthalmic

Aug 2008

Decision

14d

Days

Class 1

Risk

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

Submitted by Schwind Eye-Tech-Solutions GmbH & Co. KG (Kleinostheim, DE). The FDA issued a Cleared decision on August 1, 2008, 14 days after receiving the submission on July 18, 2008.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K082043 FDA.gov
FDA Decision	Cleared 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