Clearance Summary
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 received FDA 510(k) clearance under submission number K221466, sponsored by Shenzhen Century Dongyuan Technology CO , Ltd.. 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 2022-08-12.
- Submission: K221466
- Applicant / Sponsor: Shenzhen Century Dongyuan Technology CO , Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2022-08-12
Classification & Regulation
This clearance is catalogued under FDA product code OHT and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.