Clearance Summary
HI-EMT MAGSHAPE received FDA 510(k) clearance under submission number K230024, sponsored by Beijing Sano Laser S&T Development Co.,Ltd. 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 2023-09-06.
- Submission: K230024
- Applicant / Sponsor: Beijing Sano Laser S&T Development Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2023-09-06
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.