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FDA 510(k)

Diode laser therapy device (VADER)

K-Number: K251457 · 2025-09-03

ApplicantBeijing Superlaser Technology Co., Ltd.
Decision Date2025-09-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode laser therapy device (VADER) is a medical device manufactured by Beijing Superlaser Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-03 under approval number K251457. 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 therapy device (VADER)?

Diode laser therapy device (VADER) is a medical device that received FDA 510(k) clearance on 2025-09-03. It is manufactured by Beijing Superlaser Technology Co., Ltd.. The 510(k) number is K251457.

When was Diode laser therapy device (VADER) approved by the FDA?

Diode laser therapy device (VADER) received FDA 510(k) clearance on 2025-09-03, under approval number K251457.

What company makes Diode laser therapy device (VADER)?

Diode laser therapy device (VADER) is manufactured by Beijing Superlaser Technology Co., Ltd..

What is the FDA product code for Diode laser therapy device (VADER)?

The FDA product code for Diode laser therapy device (VADER) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 34161248 Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review. IEEE journal of biomedical and health informatics (2021) PMID: 31408733 Error Types and Associations of Clinically Significant Events Within Food and Drug Administration Recalls of Linear Accelerators and Related Products. Practical radiation oncology (2020) PMID: 30596410 Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses. Final order. Federal register (2018)

Other Devices by Beijing Superlaser Technology Co., Ltd.

K192516Diode Laser 808nm K192519Multi-modality workstation K200042CO2 Laser System K193464ND:YAG Laser

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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