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FDA 510(k)

PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS

K-Number: K083616 · 2009-06-12

ApplicantPatholase, Inc.
Decision Date2009-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Patholase, Inc.. It received FDA 510(k) clearance on 2009-06-12 under 510(k) number K083616. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS?

PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Patholase, Inc.. The 510(k) number is K083616.

When did PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS receive FDA 510(k) clearance?

PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS received FDA 510(k) clearance on 2009-06-12, under 510(k) number K083616.

Who is the listed applicant for PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS?

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

What is the FDA product code for PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS?

The FDA product code for PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS is GEX. This falls under the Gastroenterology category.

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Official Source

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

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