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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 a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-03-13 under approval 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. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K253391.

When was Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) approved by the FDA?

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 approval number K253391.

What company makes 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 manufactured by Medtronic Navigation, Inc..

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.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Medtronic Navigation, Inc.

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Related Devices (Code: ONO)

K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. K240877Monteris Medical NeuroBlate SystemMonteris Medical, K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)Clinical Laserthermia Systems, AB K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation K260976NeuroBlate SystemMonteris Medical

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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