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FDA 510(k)

ZYOPTIX XP MICROKERATOME

K-Number: K040204 · 2004-03-22

ApplicantBausch & Lomb, Inc.
Decision Date2004-03-22
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZYOPTIX XP MICROKERATOME 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 2004-03-22 under 510(k) number K040204. 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 MICROKERATOME?

ZYOPTIX XP MICROKERATOME is a medical device that received FDA 510(k) clearance on 2004-03-22. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K040204.

When did ZYOPTIX XP MICROKERATOME receive FDA 510(k) clearance?

ZYOPTIX XP MICROKERATOME received FDA 510(k) clearance on 2004-03-22, under 510(k) number K040204.

Who is the listed applicant for ZYOPTIX XP MICROKERATOME?

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 MICROKERATOME?

The FDA product code for ZYOPTIX XP MICROKERATOME is HNO.

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Other records listing Bausch & Lomb, Inc. as applicant

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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.

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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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