Clearance Summary
Vydence Zye and Vydence One received FDA 510(k) clearance under submission number K202998, sponsored by Vydence Medical Industria E Comercio Ltda. 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 2021-10-26.
- Submission: K202998
- Applicant / Sponsor: Vydence Medical Industria E Comercio Ltda
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2021-10-26
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.