Clearance Summary
SmoothCool HR System received FDA 510(k) clearance under submission number K213484, sponsored by Jeisys Medical, Inc.. 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 2022-04-20.
- Submission: K213484
- Applicant / Sponsor: Jeisys Medical, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2022-04-20
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.