Fraxis
K-Number: K172096 · 2017-08-09
ApplicantIlooda Co,., Ltd.
Decision Date2017-08-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Fraxis is a medical device manufactured by Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2017-08-09 under approval number K172096. 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 Fraxis?
Fraxis is a medical device that received FDA 510(k) clearance on 2017-08-09. It is manufactured by Ilooda Co,., Ltd.. The 510(k) number is K172096.
When was Fraxis approved by the FDA?
Fraxis received FDA 510(k) clearance on 2017-08-09, under approval number K172096.
What company makes Fraxis?
Fraxis is manufactured by Ilooda Co,., Ltd..
What is the FDA product code for Fraxis?
The FDA product code for Fraxis is GEX. This falls under the Gastroenterology category.
Other Devices by Ilooda Co,., Ltd.
Related Devices (Code: GEX)
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.
K163222Discovery Pico FamilyQuanta System Spa
K163009LithoQuanta System Spa
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.
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.