Clearance Summary
BeShape One Device received FDA 510(k) clearance under submission number K231628, sponsored by Beshape Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-09-29.
- Submission: K231628
- Applicant / Sponsor: Beshape Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4590
- Decision date: 2023-09-29
Classification & Regulation
This clearance is catalogued under FDA product code OHV and 21 CFR 878.4590, within the General, Plastic Surgery review panel as a Class II device.