K241785 is an FDA 510(k) clearance for the StarFormer (M008-3T). This device is classified as a Electromagnetic Stimulator, Pain Relief (Class II - Special Controls, product code QPL).
Submitted by Fotona D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on March 27, 2025, 280 days after receiving the submission on June 20, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890. Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain..
| 510(k) Number | K241785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2024 |
| Decision Date | March 27, 2025 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | QPL - Electromagnetic Stimulator, Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain. |