Litho 150, Cyber Ho 150
K-Number: K201455 · 2020-06-30
ApplicantQuanta System Spa
Decision Date2020-06-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Litho 150, Cyber Ho 150 is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2020-06-30 under approval number K201455. 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 Litho 150, Cyber Ho 150?
Litho 150, Cyber Ho 150 is a medical device that received FDA 510(k) clearance on 2020-06-30. It is manufactured by Quanta System Spa. The 510(k) number is K201455.
When was Litho 150, Cyber Ho 150 approved by the FDA?
Litho 150, Cyber Ho 150 received FDA 510(k) clearance on 2020-06-30, under approval number K201455.
What company makes Litho 150, Cyber Ho 150?
Litho 150, Cyber Ho 150 is manufactured by Quanta System Spa.
What is the FDA product code for Litho 150, Cyber Ho 150?
The FDA product code for Litho 150, Cyber Ho 150 is GEX. This falls under the Gastroenterology category.
Other Devices by Quanta System Spa
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.