Clearance Summary
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) received FDA 510(k) clearance under submission number K240649, sponsored by Shenzhen Ulike Smart Electronics 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 2024-06-21.
- Submission: K240649
- Applicant / Sponsor: Shenzhen Ulike Smart Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-06-21
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.