Clearance Summary
ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900 received FDA 510(k) clearance under submission number K861447, sponsored by Southern Exposure, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1986-05-13.
- Submission: K861447
- Applicant / Sponsor: Southern Exposure, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1986-05-13
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.