Litho
K-Number: K163009 · 2016-12-01
ApplicantQuanta System Spa
Decision Date2016-12-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Litho is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2016-12-01 under approval number K163009. 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?
Litho is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Quanta System Spa. The 510(k) number is K163009.
When was Litho approved by the FDA?
Litho received FDA 510(k) clearance on 2016-12-01, under approval number K163009.
What company makes Litho?
Litho is manufactured by Quanta System Spa.
What is the FDA product code for Litho?
The FDA product code for Litho 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
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.
K162914VenaCure EVLT NeverTouch Procedure KitAngioDynamics, Inc.
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.