K251298

Substantially Equivalent

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: ONO
Advisory panel: General, Plastic Surgery
Date received: 2025-04-28
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

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