Syneron CO2RE System
K-Number: K181523 · 2018-07-11
ApplicantSyneron-Candela Corp
Decision Date2018-07-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Syneron CO2RE System is a medical device manufactured by Syneron-Candela Corp. It received FDA 510(k) clearance on 2018-07-11 under approval number K181523. 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 Syneron CO2RE System?
Syneron CO2RE System is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by Syneron-Candela Corp. The 510(k) number is K181523.
When was Syneron CO2RE System approved by the FDA?
Syneron CO2RE System received FDA 510(k) clearance on 2018-07-11, under approval number K181523.
What company makes Syneron CO2RE System?
Syneron CO2RE System is manufactured by Syneron-Candela Corp.
What is the FDA product code for Syneron CO2RE System?
The FDA product code for Syneron CO2RE System is GEX. This falls under the Gastroenterology category.
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.