Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- QQOCranial Measurement Software1Product Code
- HSTApparatus, Traction, Non-Powered1Product Code
- ONONeurosurgical Laser With Mr Thermography2Product Code
- K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)2Cleared 510(K)
- K250307Visualase V2 MRI-guided Laser Ablation System (9736422)2Cleared 510(K)
- K240877Monteris Medical NeuroBlate System2Cleared 510(K)
- K214125TRANBERG Thermoguide Therapy System2Cleared 510(K)
- K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)2Cleared 510(K)
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K251298
- 510(k) Type
- Traditional
- Applicant
- Clinical Laserthermia Systems AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/4/2025
- Days to Decision
- 129 days
- Submission Type
- Summary