Cleared Special

Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

K251759 · Boston Scientific Corporation · Gastroenterology & Urology

Jul 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K251759 is an FDA 510(k) clearance for the Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on July 9, 2025, 30 days after receiving the submission on June 9, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K251759 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2025
Decision Date	July 09, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	GEX — Powered Laser Surgical Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.