Diode Laser System
K-Number: K181019 · 2018-07-16
Decision Date2018-07-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode Laser System is a medical device manufactured by Guangzhou Huafei Tongda Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-07-16 under approval number K181019. 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 Diode Laser System?
Diode Laser System is a medical device that received FDA 510(k) clearance on 2018-07-16. It is manufactured by Guangzhou Huafei Tongda Technology Co., Ltd.. The 510(k) number is K181019.
When was Diode Laser System approved by the FDA?
Diode Laser System received FDA 510(k) clearance on 2018-07-16, under approval number K181019.
What company makes Diode Laser System?
Diode Laser System is manufactured by Guangzhou Huafei Tongda Technology Co., Ltd..
What is the FDA product code for Diode Laser System?
The FDA product code for Diode Laser System is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT07607496
MacuTherm Performance Study in Patients With iAMD
NOT_YET_RECRUITING
NCT07607028
Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth
COMPLETED
NCT07101809
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
RECRUITING
NCT07593508
Diode Laser-Assisted Direct Pulp Capping Trial
COMPLETED
NCT07214220
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
RECRUITING
NCT07580560
Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study
COMPLETED
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.