Clearance Summary
XENON LIGHT SOURCE PES 1 received FDA 510(k) clearance under submission number K992540, sponsored by Laser Optik Systeme GmbH & Co. KG. 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 1999-09-14.
- Submission: K992540
- Applicant / Sponsor: Laser Optik Systeme GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1999-09-14
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.