Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Diode Laser Therapy Device (DF-DIODE LASER-S1)

K-Number: K241547 · 2024-08-13

ApplicantWeifang Dragonfly Electronics Technology Co., Ltd.
Decision Date2024-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy Device (DF-DIODE LASER-S1) is a medical device manufactured by Weifang Dragonfly Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under approval number K241547. 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 (DF-DIODE LASER-S1)?

Diode Laser Therapy Device (DF-DIODE LASER-S1) is a medical device that received FDA 510(k) clearance on 2024-08-13. It is manufactured by Weifang Dragonfly Electronics Technology Co., Ltd.. The 510(k) number is K241547.

When was Diode Laser Therapy Device (DF-DIODE LASER-S1) approved by the FDA?

Diode Laser Therapy Device (DF-DIODE LASER-S1) received FDA 510(k) clearance on 2024-08-13, under approval number K241547.

What company makes Diode Laser Therapy Device (DF-DIODE LASER-S1)?

Diode Laser Therapy Device (DF-DIODE LASER-S1) is manufactured by Weifang Dragonfly Electronics Technology Co., Ltd..

What is the FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

The FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07615361 Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy ENROLLING_BY_INVITATION NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT07615920 HILT vs ESWT in Supraspinatus Tendinitis NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

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.

↑