Clearance Summary
iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert received FDA 510(k) clearance under submission number K162231, sponsored by Cyden Limited. 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 2016-11-16.
- Submission: K162231
- Applicant / Sponsor: Cyden Limited
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2016-11-16
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.