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510(k) K214125

TRANBERG Thermoguide Therapy System by Clinical Laserthermia Systems, AB — Product Code ONO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2022
Date Received
December 30, 2021
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 Clinical Laserthermia Systems, AB

  • K251298 — Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (September 4, 2025)
  • K201466 — Tranberg CLS Laser Applicator (March 26, 2021)
  • K163103 — Tranberg CLS Diffusor Laser Fiber (March 23, 2017)
  • K151569 — Tranberg CLS Laser Fiber (February 12, 2016)
  • K142216 — Tranberg CLS Thermal Therapy System (April 21, 2015)

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)
  • K240877 — Monteris Medical NeuroBlate System (June 4, 2024)
  • K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4) (January 7, 2022)