Clearance Summary
AuraGen 123 Suction Lipoplasty System (A123) received FDA 510(k) clearance under submission number K190278, sponsored by Auragen Aesthetics, LLC. 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 2019-05-03.
- Submission: K190278
- Applicant / Sponsor: Auragen Aesthetics, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2019-05-03
Classification & Regulation
This clearance is catalogued under FDA product code MUU and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.