Clearance Summary
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS received FDA 510(k) clearance under submission number K131229, sponsored by American Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2013-12-05.
- Submission: K131229
- Applicant / Sponsor: American Medical Systems
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2013-12-05
Classification & Regulation
This clearance is catalogued under FDA product code OTN and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.