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FDA 510(k)

ZYOPTIX XP EPI SEPARATOR SYSTEM

K-Number: K062465 · 2006-09-06

ApplicantBausch & Lomb, Inc.
Decision Date2006-09-06
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZYOPTIX XP EPI SEPARATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2006-09-06 under 510(k) number K062465. 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 ZYOPTIX XP EPI SEPARATOR SYSTEM?

ZYOPTIX XP EPI SEPARATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-06. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K062465.

When did ZYOPTIX XP EPI SEPARATOR SYSTEM receive FDA 510(k) clearance?

ZYOPTIX XP EPI SEPARATOR SYSTEM received FDA 510(k) clearance on 2006-09-06, under 510(k) number K062465.

Who is the listed applicant for ZYOPTIX XP EPI SEPARATOR SYSTEM?

The FDA 510(k) record lists Bausch & Lomb, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZYOPTIX XP EPI SEPARATOR SYSTEM?

The FDA product code for ZYOPTIX XP EPI SEPARATOR SYSTEM is HNO.

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Other records listing Bausch & Lomb, Inc. 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.

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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 GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK052891HORIZON 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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