Mobile Laser Unit (1001-N2) +3 more— 510(k) K251298

Name: FDA 510(k) clearance K251298
Creator: U.S. Food and Drug Administration
Published: 2025-09-04

Substantially Equivalent

Clinical Laserthermia Systems, AB

FDA 510(k) clearance K251298 for Mobile Laser Unit (1001-N2) +3 more, Substantially Equivalent on 2025-09-04. Applicant: Clinical Laserthermia Systems, AB. Device class: 2.

Clearance details

Device name as filed: Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
Applicant: Clinical Laserthermia Systems, AB
Product code: Code ONO
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-04-28
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

Download summary PDF View on FDA.gov ↗

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