K253391
- 510(k) number
- K253391
- Device name
- Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
- Applicant
- Medtronic Navigation, Inc. CO · US
- Product code
- ONO — Neurosurgical Laser With Mr Thermography
- Decision date
- 2026-03-13
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253391.pdf
Official FDA record: K253391
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.