K241785
- 510(k) number
- K241785
- Device name
- StarFormer (M008-3T)
- Applicant
- Fotona D.O.O. SI
- Product code
- QPL — Electromagnetic Stimulator, Pain Relief
- Decision date
- 2025-03-27
- Date received
- 2024-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K241785.pdf
Official FDA record: K241785
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.