Clearance Summary
High Intensity Focused Electromagnetic Stimulation Device (FE60) received FDA 510(k) clearance under submission number K253790, sponsored by Beijing Winkonlaser Technology Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2026-08-13.
- Submission: K253790
- Applicant / Sponsor: Beijing Winkonlaser Technology Limited
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2026-08-13
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.