Clearance Summary
COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE received FDA 510(k) clearance under submission number K933405, sponsored by Cogent Light 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 1994-02-18.
- Submission: K933405
- Applicant / Sponsor: Cogent Light Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-02-18
Classification & Regulation
This clearance is catalogued under FDA product code GCT and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.