Clearance Summary
APVolution System received FDA 510(k) clearance under submission number K163228, sponsored by Aesthetic-Press, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-06-05.
- Submission: K163228
- Applicant / Sponsor: Aesthetic-Press, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2017-06-05
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.