Clearance Summary
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece received FDA 510(k) clearance under submission number K202112, sponsored by Storz Medical AG. 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 2021-02-21.
- Submission: K202112
- Applicant / Sponsor: Storz Medical AG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4685
- Decision date: 2021-02-21
Classification & Regulation
This clearance is catalogued under FDA product code PZL and 21 CFR 878.4685, within the General, Plastic Surgery review panel as a Class II device.