Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)— 510(k) K251298
Substantially EquivalentClinical Laserthermia Systems, AB
FDA 510(k) clearance K251298 for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6), Substantially Equivalent on 2025-09-04. Applicant: Clinical Laserthermia Systems, AB.
Clearance details
- Applicant
- Clinical Laserthermia Systems, AB
- Product code
- Code ONO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lund, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.