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FDA 510(k)

HANSATOME MICROKERATOME

K-Number: K010260 · 2001-04-27

ApplicantBausch & Lomb, Inc.
Decision Date2001-04-27
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HANSATOME 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 2001-04-27 under 510(k) number K010260. 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 HANSATOME MICROKERATOME?

HANSATOME MICROKERATOME is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K010260.

When did HANSATOME MICROKERATOME receive FDA 510(k) clearance?

HANSATOME MICROKERATOME received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010260.

Who is the listed applicant for HANSATOME 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 HANSATOME MICROKERATOME?

The FDA product code for HANSATOME MICROKERATOME is HNO.

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Other records listing Bausch & Lomb, Inc. as applicant

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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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