Clearance Summary
LUXTEC MLX LIGHT SOURCE received FDA 510(k) clearance under submission number K081477, sponsored by Integra Luxtec, 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 2008-06-18.
- Submission: K081477
- Applicant / Sponsor: Integra Luxtec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2008-06-18
Classification & Regulation
This clearance is catalogued under FDA product code FCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.