FDA 510(k)

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

K-Nummer: K251298 · 2025-09-04

AntragstellerClinical Laserthermia Systems, AB

Entscheidungsdatum2025-09-04

ProduktcodeONO

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251298. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)?

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Clinical Laserthermia Systems, AB. The 510(k) number is K251298.

When did Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) receive FDA 510(k) clearance?

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251298.

Who is the listed applicant for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)?

The FDA 510(k) record lists Clinical Laserthermia Systems, AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)?

The FDA product code for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) is ONO.

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