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FDA 510(k)

INPULSE LASER

K-Number: K131805 · 2013-07-18

ApplicantIncisive, Inc.
Decision Date2013-07-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INPULSE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Incisive, Inc.. It received FDA 510(k) clearance on 2013-07-18 under 510(k) number K131805. 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 INPULSE LASER?

INPULSE LASER is a medical device that received FDA 510(k) clearance on 2013-07-18. The listed applicant is Incisive, Inc.. The 510(k) number is K131805.

When did INPULSE LASER receive FDA 510(k) clearance?

INPULSE LASER received FDA 510(k) clearance on 2013-07-18, under 510(k) number K131805.

Who is the listed applicant for INPULSE LASER?

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

What is the FDA product code for INPULSE LASER?

The FDA product code for INPULSE LASER 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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