CO2 Laser Equipment
K-Number: K212611 · 2022-02-01
Decision Date2022-02-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CO2 Laser Equipment is a medical device manufactured by Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2022-02-01 under approval number K212611. 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 CO2 Laser Equipment?
CO2 Laser Equipment is a medical device that received FDA 510(k) clearance on 2022-02-01. It is manufactured by Beijing Globalipl Development Co., Ltd.. The 510(k) number is K212611.
When was CO2 Laser Equipment approved by the FDA?
CO2 Laser Equipment received FDA 510(k) clearance on 2022-02-01, under approval number K212611.
What company makes CO2 Laser Equipment?
CO2 Laser Equipment is manufactured by Beijing Globalipl Development Co., Ltd..
What is the FDA product code for CO2 Laser Equipment?
The FDA product code for CO2 Laser Equipment is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
Other Devices by Beijing Globalipl Development Co., Ltd.
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.