Cleared Traditional

NeuroBlate System

K182036 · Monteris Medical, · Neurology

Oct 2018

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K182036 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 October 15, 2018, 77 days after receiving the submission on July 30, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K182036 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2018
Decision Date	October 15, 2018
Days to Decision	77 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.