FDA 510(k)

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)

K-Number: K250656 · 2025-04-04

ApplicantWuhan Pioon Technology Co., Ltd.

Decision Date2025-04-04

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is a medical device manufactured by Wuhan Pioon Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-04 under approval number K250656. 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 (Models: MZ-GK, MZ-K20, MZ-N75)?

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K250656.

When was Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) approved by the FDA?

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) received FDA 510(k) clearance on 2025-04-04, under approval number K250656.

What company makes Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)?

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is manufactured by Wuhan Pioon Technology Co., Ltd..

What is the FDA product code for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)?

The FDA product code for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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 NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07564739 Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds RECRUITING NCT07099352 Efficacy of of Acupuncture Laser Therapy on Hemodialysis Patients NOT_YET_RECRUITING NCT07573150 Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy RECRUITING

Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41858417 AI-Driven Medical Device Risk Management: A New Paradigm Integrating Large Language Models and Prompt Engineering for Standard-Risk Knowledge Graph Construction and Application. Risk management and healthcare policy (2026) PMID: 41857339 Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ digital medicine (2026)

Other Devices by Wuhan Pioon Technology Co., Ltd.

K231548Medical Diode Laser, Model S1Pro K230274Medical Diode Laser (M2) K240747Medical Diode Laser (M2-GK) K240644Medical Diode Laser (S1Pro) K240179Medical Diode Laser (Model: L2) K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

View all 7 devices →

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.