Clearance Summary
ALPHAXENON LIGHT 180 W AND 300 W received FDA 510(k) clearance under submission number K093125, sponsored by Gimmi GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-01-27.
- Submission: K093125
- Applicant / Sponsor: Gimmi GmbH
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-01-27
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.