CLARITY II Laser System
K-Number: K183566 · 2019-06-14
ApplicantLutronic Corporation
Decision Date2019-06-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CLARITY II Laser System is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2019-06-14 under approval number K183566. 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 CLARITY II Laser System?
CLARITY II Laser System is a medical device that received FDA 510(k) clearance on 2019-06-14. It is manufactured by Lutronic Corporation. The 510(k) number is K183566.
When was CLARITY II Laser System approved by the FDA?
CLARITY II Laser System received FDA 510(k) clearance on 2019-06-14, under approval number K183566.
What company makes CLARITY II Laser System?
CLARITY II Laser System is manufactured by Lutronic Corporation.
What is the FDA product code for CLARITY II Laser System?
The FDA product code for CLARITY 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.