Clearance Summary
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) received FDA 510(k) clearance under submission number K233887, sponsored by Shenzhen Ulike Smart Electronics 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 2024-01-22.
- Submission: K233887
- Applicant / Sponsor: Shenzhen Ulike Smart Electronics Co., Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-01-22
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.