Lithoblast Single Use Holmium Laser Fibers
K-Number: K250776 · 2025-10-14
ApplicantDawell Medical, LLC
Decision Date2025-10-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Lithoblast Single Use Holmium Laser Fibers is a medical device manufactured by Dawell Medical, LLC. It received FDA 510(k) clearance on 2025-10-14 under approval number K250776. 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 Lithoblast Single Use Holmium Laser Fibers?
Lithoblast Single Use Holmium Laser Fibers is a medical device that received FDA 510(k) clearance on 2025-10-14. It is manufactured by Dawell Medical, LLC. The 510(k) number is K250776.
When was Lithoblast Single Use Holmium Laser Fibers approved by the FDA?
Lithoblast Single Use Holmium Laser Fibers received FDA 510(k) clearance on 2025-10-14, under approval number K250776.
What company makes Lithoblast Single Use Holmium Laser Fibers?
Lithoblast Single Use Holmium Laser Fibers is manufactured by Dawell Medical, LLC.
What is the FDA product code for Lithoblast Single Use Holmium Laser Fibers?
The FDA product code for Lithoblast Single Use Holmium Laser Fibers is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT06958731
In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial
ENROLLING_BY_INVITATION
NCT07137728
Dual Frequency Low-Level Laser Therapy in Myofascial Trigger Points of Upper Trapezius
COMPLETED
NCT07557589
Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months
RECRUITING
NCT07607028
Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth
COMPLETED
NCT07605234
Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies
NOT_YET_RECRUITING
NCT07580404
Emsella for Reducing tSUI After HOLEP
NOT_YET_RECRUITING
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.