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FDA 510(k)

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

K-Number: K253391 · 2026-03-13

ApplicantMedtronic Navigation, Inc.
Decision Date2026-03-13
Product CodeONO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K253391. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)?

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K253391.

When did Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) receive FDA 510(k) clearance?

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) received FDA 510(k) clearance on 2026-03-13, under 510(k) number K253391.

Who is the listed applicant for Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)?

The FDA product code for Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) is ONO.

Related Clinical Trials

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NCT02759744Fusion Guided Focal Laser Ablation of Prostate CancerENROLLING_BY_INVITATION

Other records listing Medtronic Navigation, Inc. as applicant

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K253379Stealth AXiS Cranial clinical applicationK253395Stealth AXiS™ ENT clinical applicationK253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationK251282StealthStation S8 Spine SoftwareK242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsK250307Visualase V2 MRI-guided Laser Ablation System (9736422)

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Related Devices (Code: ONO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260976NeuroBlate SystemMonteris MedicalK251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)Clinical Laserthermia Systems, ABK250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic NavigationK240877Monteris Medical NeuroBlate SystemMonteris Medical,K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, ABK211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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