510(k) K241785
K241785 is an FDA 510(k) premarket notification submitted by Fotona D.O.O. for the device "StarFormer (M008-3T)". The FDA issued a decision of Substantially Equivalent on March 27, 2025. The device falls under product code QPL (Electromagnetic Stimulator, Pain Relief), a Class II device regulated under 21 CFR 882.5890. Fotona D.O.O. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2025
- Date Received
- June 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromagnetic Stimulator, Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- PM
- Submission Type
Intended to apply a magnetic-field induced electrical current to treat pain.