xeo+ Family
K-Number: K233237 · 2023-12-15
ApplicantCutera, Inc.
Decision Date2023-12-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
xeo+ Family is a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2023-12-15 under approval number K233237. 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 xeo+ Family?
xeo+ Family is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Cutera, Inc.. The 510(k) number is K233237.
When was xeo+ Family approved by the FDA?
xeo+ Family received FDA 510(k) clearance on 2023-12-15, under approval number K233237.
What company makes xeo+ Family?
xeo+ Family is manufactured by Cutera, Inc..
What is the FDA product code for xeo+ Family?
The FDA product code for xeo+ Family is GEX. This falls under the Gastroenterology category.
Other Devices by Cutera, Inc.
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.