Clearance Summary
IPL Home Use Hair Removal Device (SJ15) received FDA 510(k) clearance under submission number K240093, sponsored by Shenzhen Shuge Medical Beauty Devices 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 2024-04-24.
- Submission: K240093
- Applicant / Sponsor: Shenzhen Shuge Medical Beauty Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-04-24
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.