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FDA 510(k)

INCISIVE FAMILY OF INPULSE ND:YAG LASERS

K-Number: K083215 · 2009-04-08

ApplicantIncisive, LLC
Decision Date2009-04-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCISIVE FAMILY OF INPULSE ND:YAG LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Incisive, LLC. It received FDA 510(k) clearance on 2009-04-08 under 510(k) number K083215. 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 INCISIVE FAMILY OF INPULSE ND:YAG LASERS?

INCISIVE FAMILY OF INPULSE ND:YAG LASERS is a medical device that received FDA 510(k) clearance on 2009-04-08. The listed applicant is Incisive, LLC. The 510(k) number is K083215.

When did INCISIVE FAMILY OF INPULSE ND:YAG LASERS receive FDA 510(k) clearance?

INCISIVE FAMILY OF INPULSE ND:YAG LASERS received FDA 510(k) clearance on 2009-04-08, under 510(k) number K083215.

Who is the listed applicant for INCISIVE FAMILY OF INPULSE ND:YAG LASERS?

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

What is the FDA product code for INCISIVE FAMILY OF INPULSE ND:YAG LASERS?

The FDA product code for INCISIVE FAMILY OF INPULSE ND:YAG LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Incisive, LLC as applicant

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.

K011423INPULSE DENTAL LASER

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Official Source

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