Medical Diode Laser, Model S1Pro
K-Number: K231548 · 2023-08-03
ApplicantWuhan Pioon Technology Co., Ltd.
Decision Date2023-08-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medical Diode Laser, Model S1Pro is a medical device manufactured by Wuhan Pioon Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-03 under approval number K231548. 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 Medical Diode Laser, Model S1Pro?
Medical Diode Laser, Model S1Pro is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K231548.
When was Medical Diode Laser, Model S1Pro approved by the FDA?
Medical Diode Laser, Model S1Pro received FDA 510(k) clearance on 2023-08-03, under approval number K231548.
What company makes Medical Diode Laser, Model S1Pro?
Medical Diode Laser, Model S1Pro is manufactured by Wuhan Pioon Technology Co., Ltd..
What is the FDA product code for Medical Diode Laser, Model S1Pro?
The FDA product code for Medical Diode Laser, Model S1Pro is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT07607457
Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery
NOT_YET_RECRUITING
NCT07607028
Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth
COMPLETED
NCT07593508
Diode Laser-Assisted Direct Pulp Capping Trial
COMPLETED
NCT07572253
A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation
NOT_YET_RECRUITING
NCT07214220
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
RECRUITING
NCT07589946
Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases
COMPLETED
Related PubMed Literature
PMID: 42174919
Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data.
Studies in health technology and informatics (2026)
PMID: 41915420
Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study.
JMIR medical informatics (2026)
PMID: 41831468
Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study.
The lancet. Psychiatry (2026)
PMID: 41501972
First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics.
ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)
Other Devices by Wuhan Pioon Technology 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.