Clearance Summary
Nam illumination probe with chopper received FDA 510(k) clearance under submission number K202670, sponsored by Oculight , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-08-20.
- Submission: K202670
- Applicant / Sponsor: Oculight , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-08-20
Classification & Regulation
This clearance is catalogued under FDA product code MPA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.