Visualase Cooled Laser Applicator System (3 models)— 510(k) K253391

Name: FDA 510(k) clearance K253391
Creator: U.S. Food and Drug Administration
Published: 2026-03-13

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K253391 for Visualase Cooled Laser Applicator System (3 models), Substantially Equivalent on 2026-03-13. Applicant: Medtronic Navigation, Inc.. Device class: 2.

Clearance details

Device name as filed: Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
Applicant: Medtronic Navigation, Inc.
Product code: Code ONO
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-09-30
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

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