Cleared Traditional

K222983 - NeuroBlate Fusion-S Software V3.17
(FDA 510(k) Clearance)

K222983 · Monteris Medical, · Neurology

Mar 2023

Decision

168d

Days

Class 2

Risk

K222983 is an FDA 510(k) clearance for the NeuroBlate Fusion-S Software V3.17, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Monteris Medical, (Minnetonka, US). The FDA issued a Cleared decision on March 15, 2023, 168 days after receiving the submission on September 28, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K222983 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2022
Decision Date	March 15, 2023
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Neurology (NE)
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.