Clearance Summary
Shani Darden LED light therapy mask received FDA 510(k) clearance under submission number K214103, sponsored by Harpar Grace International. 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 2022-03-22.
- Submission: K214103
- Applicant / Sponsor: Harpar Grace International
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2022-03-22
Classification & Regulation
This clearance is catalogued under FDA product code OLP and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.