Clearance Summary
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII received FDA 510(k) clearance under submission number K062895, sponsored by Dutch Ophthalmic Research Center International BV. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2006-10-13.
- Submission: K062895
- Applicant / Sponsor: Dutch Ophthalmic Research Center International BV
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2006-10-13
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.