Matrix LS-40 CO2 Laser System
K-Number: K161356 · 2016-09-09
Decision Date2016-09-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Matrix LS-40 CO2 Laser System is a medical device manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2016-09-09 under approval number K161356. 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 Matrix LS-40 CO2 Laser System?
Matrix LS-40 CO2 Laser System is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K161356.
When was Matrix LS-40 CO2 Laser System approved by the FDA?
Matrix LS-40 CO2 Laser System received FDA 510(k) clearance on 2016-09-09, under approval number K161356.
What company makes Matrix LS-40 CO2 Laser System?
Matrix LS-40 CO2 Laser System is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd.
What is the FDA product code for Matrix LS-40 CO2 Laser System?
The FDA product code for Matrix LS-40 CO2 Laser System is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT07607496
MacuTherm Performance Study in Patients With iAMD
NOT_YET_RECRUITING
NCT07101809
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
RECRUITING
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
NCT06795451
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
RECRUITING
NCT07340671
Facial Papules in Frontal Fibrosing Alopecia (FFA)
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 42168293
Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling.
Scientific reports (2026)
PMID: 40407411
A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology.
JASA express letters (2025)
Other Devices by Shanghai Wonderful Opto-Electrics Tech.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.