TRANBERG Thermoguide Therapy System— 510(k) K214125

Name: FDA 510(k) clearance K214125
Creator: U.S. Food and Drug Administration
Published: 2022-09-22

Substantially Equivalent

Clinical Laserthermia Systems, AB

FDA 510(k) clearance K214125 for TRANBERG Thermoguide Therapy System, Substantially Equivalent on 2022-09-22. Applicant: Clinical Laserthermia Systems, AB. Device class: 2.

Clearance details

Applicant: Clinical Laserthermia Systems, AB
Product code: Code ONO
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-12-30
Decision date: 2022-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONO

view all

K262315 — NeuroBlate System2026-09-03
K260976 — NeuroBlate System2026-04-23
K253391 — Visualase Cooled Laser Applicator System (3 models)2026-03-13
K251298 — Mobile Laser Unit (1001-N2) +3 more2025-09-04
K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422)2025-05-29

More clearances from Clinical Laserthermia Systems, AB

view all

K201466 — Tranberg CLS Laser Applicator2021-03-26
K163103 — Tranberg CLS Diffusor Laser Fiber2017-03-23
K151569 — Tranberg CLS Laser Fiber2016-02-12
K142216 — Tranberg CLS Thermal Therapy System2015-04-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.