Clearance Summary
Bonvadis® received FDA 510(k) clearance under submission number K261638, sponsored by Oneness Biotech Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-06-17.
- Submission: K261638
- Applicant / Sponsor: Oneness Biotech Co., Ltd.
- Clearance pathway: Special
- Review panel: Unknown
- Device class:
- Decision date: 2026-06-17
Classification & Regulation
This clearance is catalogued under FDA product code FRO , within the Unknown review panel as a device.