MONTERIS MEDICAL CORP

FDA Device Registration & Listing · Minnetonka, MN, US · Registration 3009970070

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009970070
FEI Number
3009970070
Entity Name
MONTERIS MEDICAL CORP
City/State/Country
Minnetonka, MN, US
Establishment Address
131 Cheshire Lane, Suite 100, Minnetonka, MN 55305, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Monteris Medical Corp (Owner Number: 10042500)
Owner / Operator Contact Address
131 Cheshire Lane Suite 100, Minnetonka, MN 55305, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NeuroBlate Optic M-Vision Software M-Vision Pro Fusion Software NeuroBlate M-Vision Pro Software NeuroBlate M-Vision Software M-Vision Pro Software Fusion-S Software NeuroBlate Fusion-S NeuroBlate System NeuroBlate M-Vision Pro Fusion Software M-Vision Pro Software M-Vision Software NeuroBlate AutoLITT; NeuroBlate System AtamA System M-Vision Pro Software M-Vision Software NeuroBlate M Vision NeuroBlate M-Vision Pro Software AtamA System M-Vision Pro Software M-Vision Software NeuroBlate NeuroBlate M Vision Software M-Vision Pro Software NeuroBlate System NB3 NeuroBlate Monteris Medical Mini-Bolt Adapters Monteris Medical Mini-Bolt Monteris Medical Cranial Bolt Adapters Monteris Medical Cranial Bolt Monteris AXiiiS CMB Monteris AXiiiS CMB-S Monteris Mini-Bolt -S Monteris Medical Mini-Bolt VUE Cranial Bolt Monteris AXiiiS CMB-V Monteris Medical Mini-Bolt VUE Cranial Bolt Adaptor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2026-05-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-12-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-12-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2020-12-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-12-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2015-03-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-03-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-12-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2020-12-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-12-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-12-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-12-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-12-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-12-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-12-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2012-12-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-12-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-12-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-12-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-12-02
ONO Neurosurgical Laser With Mr Thermography General, Plastic Surgery Class 2 878.4810 2024-12-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-12-13
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-12-13
ONO Neurosurgical Laser With Mr Thermography General, Plastic Surgery Class 2 878.4810 2023-12-13
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2014-07-24
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 2025-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Monteris Medical Corp
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009970070. Last updated year: 2026. Please use registration number 3009970070 when referencing this establishment in official correspondence.
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