Cleared Special

NeuroBlate System

K193375 · Monteris Medical, · Neurology

Jan 2020

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K193375 is an FDA 510(k) clearance for the NeuroBlate System, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Monteris Medical, (Plymouth, US). The FDA issued a Cleared decision on January 3, 2020, 29 days after receiving the submission on December 5, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K193375 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2019
Decision Date	January 03, 2020
Days to Decision	29 days
Submission Type	Special
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.