Clearance Summary
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR received FDA 510(k) clearance under submission number K863642, sponsored by Candela Corp.. 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 1986-12-03.
- Submission: K863642
- Applicant / Sponsor: Candela Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 1986-12-03
Classification & Regulation
This clearance is catalogued under FDA product code FFK and 21 CFR 876.4480, within the Gastroenterology, Urology review panel as a Class II device.