Visualase Cooled Laser Applicator System (3 models)— 510(k) K253391
Substantially EquivalentMedtronic 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.
Summary
Medtronic Navigation's record lists three Visualase Cooled Laser Applicator System numbers: 9735559, 9735560 and 9735561. They're filed under ONO, neurosurgical lasers with MR thermography.
Class II, 21 CFR 878.4810. The Neurology review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Medtronic Navigation filed from Lafayette, Colorado. Review took 164 calendar days (September 30, 2025 to March 13, 2026).
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
- Product code ONO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lafayette, CO, US
Recent devices under product code ONO
view allMore clearances from Medtronic Navigation, Inc.
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