FDA 510(k)

PINPOINTE FOOTLASER MODEL 6W, 30W, 100W

K-Number: K093545 · 2010-10-15

ApplicantIncisive, Inc. (Formerly Named Incisive, LLC)

Decision Date2010-10-15

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PINPOINTE FOOTLASER MODEL 6W, 30W, 100W is the device name listed in this FDA 510(k) record. The listed applicant is Incisive, Inc. (Formerly Named Incisive, LLC). It received FDA 510(k) clearance on 2010-10-15 under 510(k) number K093545. 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 MODEL 6W, 30W, 100W?

PINPOINTE FOOTLASER MODEL 6W, 30W, 100W is a medical device that received FDA 510(k) clearance on 2010-10-15. The listed applicant is Incisive, Inc. (Formerly Named Incisive, LLC). The 510(k) number is K093545.

When did PINPOINTE FOOTLASER MODEL 6W, 30W, 100W receive FDA 510(k) clearance?

PINPOINTE FOOTLASER MODEL 6W, 30W, 100W received FDA 510(k) clearance on 2010-10-15, under 510(k) number K093545.

Who is the listed applicant for PINPOINTE FOOTLASER MODEL 6W, 30W, 100W?

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

What is the FDA product code for PINPOINTE FOOTLASER MODEL 6W, 30W, 100W?

The FDA product code for PINPOINTE FOOTLASER MODEL 6W, 30W, 100W 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.