Clearance Summary
CORELEADER SCAR-DIMMER received FDA 510(k) clearance under submission number K111733, sponsored by Coreleader Biotech Co., Ltd.. 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 2011-09-22.
- Submission: K111733
- Applicant / Sponsor: Coreleader Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 2011-09-22
Classification & Regulation
This clearance is catalogued under FDA product code MDA and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.