K253391

Substantially Equivalent

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

Applicant: Medtronic Navigation, Inc.
Product code: ONO
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 ↗

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