Clearance Summary
easy Hairfull received FDA 510(k) clearance under submission number K202983, sponsored by Y & J Bio Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2020-12-08.
- Submission: K202983
- Applicant / Sponsor: Y & J Bio Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2020-12-08
Classification & Regulation
This clearance is catalogued under FDA product code OAP and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.