Clearance Summary
COLDLIGHTSOURCE PL3000 received FDA 510(k) clearance under submission number K993300, sponsored by Fiber Imaging Technologies, Inc.. 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 1999-11-05.
- Submission: K993300
- Applicant / Sponsor: Fiber Imaging Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1999-11-05
Classification & Regulation
This clearance is catalogued under FDA product code FCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.