Clearance Summary
COOLSKIN received FDA 510(k) clearance under submission number K083008, sponsored by Elbio Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2009-06-10.
- Submission: K083008
- Applicant / Sponsor: Elbio Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5720
- Decision date: 2009-06-10
Classification & Regulation
This clearance is catalogued under FDA product code ILO and 21 CFR 890.5720, within the Physical Medicine review panel as a Class II device.