Clearance Summary
SMARTO received FDA 510(k) clearance under submission number K163308, sponsored by Jeil Medical Corporation. 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 2016-12-27.
- Submission: K163308
- Applicant / Sponsor: Jeil Medical Corporation
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 2016-12-27
Classification & Regulation
This clearance is catalogued under FDA product code KIJ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.