Empower H100, Cyber Ho 100, Litho 100
K-Number: K180922 · 2018-05-08
ApplicantQuanta System Spa
Decision Date2018-05-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Empower H100, Cyber Ho 100, Litho 100 is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2018-05-08 under approval number K180922. 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 Empower H100, Cyber Ho 100, Litho 100?
Empower H100, Cyber Ho 100, Litho 100 is a medical device that received FDA 510(k) clearance on 2018-05-08. It is manufactured by Quanta System Spa. The 510(k) number is K180922.
When was Empower H100, Cyber Ho 100, Litho 100 approved by the FDA?
Empower H100, Cyber Ho 100, Litho 100 received FDA 510(k) clearance on 2018-05-08, under approval number K180922.
What company makes Empower H100, Cyber Ho 100, Litho 100?
Empower H100, Cyber Ho 100, Litho 100 is manufactured by Quanta System Spa.
What is the FDA product code for Empower H100, Cyber Ho 100, Litho 100?
The FDA product code for Empower H100, Cyber Ho 100, Litho 100 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.