AvalancheLase Family
K-Number: K223540 · 2023-01-19
ApplicantFotona D.O.O.
Decision Date2023-01-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AvalancheLase Family is a medical device manufactured by Fotona D.O.O.. It received FDA 510(k) clearance on 2023-01-19 under approval number K223540. 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 AvalancheLase Family?
AvalancheLase Family is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Fotona D.O.O.. The 510(k) number is K223540.
When was AvalancheLase Family approved by the FDA?
AvalancheLase Family received FDA 510(k) clearance on 2023-01-19, under approval number K223540.
What company makes AvalancheLase Family?
AvalancheLase Family is manufactured by Fotona D.O.O..
What is the FDA product code for AvalancheLase Family?
The FDA product code for AvalancheLase 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.