2940 nm Er:Yag Laser Handpiece
K-Number: K173002 · 2017-12-13
ApplicantQuanta System Spa
Decision Date2017-12-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
2940 nm Er:Yag Laser Handpiece is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2017-12-13 under approval number K173002. 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 2940 nm Er:Yag Laser Handpiece?
2940 nm Er:Yag Laser Handpiece is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Quanta System Spa. The 510(k) number is K173002.
When was 2940 nm Er:Yag Laser Handpiece approved by the FDA?
2940 nm Er:Yag Laser Handpiece received FDA 510(k) clearance on 2017-12-13, under approval number K173002.
What company makes 2940 nm Er:Yag Laser Handpiece?
2940 nm Er:Yag Laser Handpiece is manufactured by Quanta System Spa.
What is the FDA product code for 2940 nm Er:Yag Laser Handpiece?
The FDA product code for 2940 nm Er:Yag Laser Handpiece is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
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.