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510(k) K240877

Monteris Medical NeuroBlate System by Monteris Medical, — Product Code ONO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2024
Date Received
March 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Laser With Mr Thermography
Device Class
Class II
Regulation Number
878.4810
Review Panel
NE
Submission Type

Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.

Other clearances by Monteris Medical,

  • K231061 — NeuroBlate System (December 8, 2023)
  • K222983 — NeuroBlate Fusion-S Software V3.17 (March 15, 2023)
  • K201056 — NeuroBlate System (August 21, 2020)
  • K193375 — NeuroBlate System (January 3, 2020)
  • K182036 — NeuroBlate System (October 15, 2018)
  • K173305 — NeuroBlate System (November 17, 2017)
  • K172881 — NeuroBlate System (October 20, 2017)
  • K171255 — Monteris Medical NeuroBlate System (July 25, 2017)
  • K170724 — NeuroBlate System (April 7, 2017)
  • K162762 — NeuroBlate System (October 26, 2016)

Other clearances for product code ONO

  • K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
  • K251298 — Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (September 4, 2025)
  • K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
  • K214125 — TRANBERG Thermoguide Therapy System (September 22, 2022)
  • K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4) (January 7, 2022)