Vydence Laser Family
K-Number: K190007 · 2019-03-01
Decision Date2019-03-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Vydence Laser Family is a medical device manufactured by Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2019-03-01 under approval number K190007. 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 Vydence Laser Family?
Vydence Laser Family is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Vydence Medical Industria E Comercio Ltda. The 510(k) number is K190007.
When was Vydence Laser Family approved by the FDA?
Vydence Laser Family received FDA 510(k) clearance on 2019-03-01, under approval number K190007.
What company makes Vydence Laser Family?
Vydence Laser Family is manufactured by Vydence Medical Industria E Comercio Ltda.
What is the FDA product code for Vydence Laser Family?
The FDA product code for Vydence Laser Family 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.