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FDA 510(k)

CARRIAZO-PENDULAR MICROKERATOME

K-Number: K082043 · 2008-08-01

ApplicantSchwind Eye-Tech-Solutions GmbH & Co. KG
Decision Date2008-08-01
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CARRIAZO-PENDULAR MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Schwind Eye-Tech-Solutions GmbH & Co. KG. It received FDA 510(k) clearance on 2008-08-01 under 510(k) number K082043. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARRIAZO-PENDULAR MICROKERATOME?

CARRIAZO-PENDULAR MICROKERATOME is a medical device that received FDA 510(k) clearance on 2008-08-01. The listed applicant is Schwind Eye-Tech-Solutions GmbH & Co. KG. The 510(k) number is K082043.

When did CARRIAZO-PENDULAR MICROKERATOME receive FDA 510(k) clearance?

CARRIAZO-PENDULAR MICROKERATOME received FDA 510(k) clearance on 2008-08-01, under 510(k) number K082043.

Who is the listed applicant for CARRIAZO-PENDULAR MICROKERATOME?

The FDA 510(k) record lists Schwind Eye-Tech-Solutions GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARRIAZO-PENDULAR MICROKERATOME?

The FDA product code for CARRIAZO-PENDULAR MICROKERATOME is HNO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Schwind Eye-Tech-Solutions GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032910CARRIAZO PENDULAR

Related Devices (Code: HNO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken IndustriesK051486NORWOOD ABBEY CENTURION SES EPIKERATOMENorwood Abbey , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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