Clearance Summary
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) received FDA 510(k) clearance under submission number K252618, sponsored by Alovea Healthcare 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 2025-11-14.
- Submission: K252618
- Applicant / Sponsor: Alovea Healthcare Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2025-11-14
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.