Clearance Summary
Laser Speckle Imaging System (RFLSI CZW) received FDA 510(k) clearance under submission number K233076, sponsored by Rwd Life Science Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-05-28.
- Submission: K233076
- Applicant / Sponsor: Rwd Life Science Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2120
- Decision date: 2024-05-28
Classification & Regulation
This clearance is catalogued under FDA product code DPT and 21 CFR 870.2120, within the Cardiovascular review panel as a Class II device.