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
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GZCStimulator, Neuromuscular, Implanted3Product Code
- QPLElectromagnetic Stimulator, Pain Relief2Product Code
- K250309BTL-1992Cleared 510(K)
- K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)2Cleared 510(K)
- K241785StarFormer (M008-3T)2Cleared 510(K)
- K233364Axon Therapy2Cleared 510(K)
- K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption2Cleared 510(K)
- K210021Axon Therapy2Cleared 510(K)
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
StarFormer (M008-3T)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K241785
- 510(k) Type
- Traditional
- Applicant
- Fotona D.O.O.
- Country
- Slovenia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/27/2025
- Days to Decision
- 280 days
- Submission Type
- Summary