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FDA 510(k)

PINPOINTE FOOTLASER

K-Number: K130413 · 2013-03-21

ApplicantNuvolase, Inc.
Decision Date2013-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PINPOINTE FOOTLASER is the device name listed in this FDA 510(k) record. The listed applicant is Nuvolase, Inc.. It received FDA 510(k) clearance on 2013-03-21 under 510(k) number K130413. 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 PINPOINTE FOOTLASER?

PINPOINTE FOOTLASER is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Nuvolase, Inc.. The 510(k) number is K130413.

When did PINPOINTE FOOTLASER receive FDA 510(k) clearance?

PINPOINTE FOOTLASER received FDA 510(k) clearance on 2013-03-21, under 510(k) number K130413.

Who is the listed applicant for PINPOINTE FOOTLASER?

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

What is the FDA product code for PINPOINTE FOOTLASER?

The FDA product code for PINPOINTE FOOTLASER 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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