Visualase Thermal Therapy System— 510(k) K181859

Name: FDA 510(k) clearance K181859
Creator: U.S. Food and Drug Administration
Published: 2019-03-06

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K181859 for Visualase Thermal Therapy System, Substantially Equivalent on 2019-03-06. Applicant: Medtronic Navigation, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2018-07-12
Decision date: 2019-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Medtronic Navigation, Inc.

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K253379 — Stealth AXiS Cranial clinical application2026-03-26
K253395 — Stealth AXiS ENT clinical application2026-03-16
K253391 — Visualase Cooled Laser Applicator System (3 models)2026-03-13
K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application2026-02-12
K251282 — StealthStation S8 Spine Software2025-10-17

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K181859

K-number listed on FDA's recall record

Z-0244-2023 — Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.Class II·Ongoing·Medtronic Navigation, Inc.·20221014

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181859.

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