Clearance Summary
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 received FDA 510(k) clearance under submission number K091962, sponsored by Lumenis, 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 2009-09-30.
- Submission: K091962
- Applicant / Sponsor: Lumenis, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2009-09-30
Classification & Regulation
This clearance is catalogued under FDA product code ODF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.