ACTION II Laser System
K-Number: K163196 · 2017-05-24
ApplicantLutronic Corporation
Decision Date2017-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ACTION II Laser System is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2017-05-24 under approval number K163196. 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 ACTION II Laser System?
ACTION II Laser System is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Lutronic Corporation. The 510(k) number is K163196.
When was ACTION II Laser System approved by the FDA?
ACTION II Laser System received FDA 510(k) clearance on 2017-05-24, under approval number K163196.
What company makes ACTION II Laser System?
ACTION II Laser System is manufactured by Lutronic Corporation.
What is the FDA product code for ACTION II Laser System?
The FDA product code for ACTION II Laser System is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.