Clearance Summary
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 received FDA 510(k) clearance under submission number K223784, sponsored by Deltronix Equipamentos 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 2023-04-18.
- Submission: K223784
- Applicant / Sponsor: Deltronix Equipamentos Ltda
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2023-04-18
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.