FDA 510(k) clearance · back to tracker
Visualase V2 MRI-guided Laser Ablation System (9736422)
Medtronic Navigation cleared K250307 on 2025-05-29, decision: substantially equivalent
K-number
K250307
Sponsor
Medtronic Navigation
Device
Visualase V2 MRI-guided Laser Ablation System (9736422)
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-05-29
Product code
ONO
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.4810
Official FDA record
Open K250307on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.