Clearance Summary
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape received FDA 510(k) clearance under submission number K201863, sponsored by Somatex Medical Technologies GmbH. 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 2021-02-18.
- Submission: K201863
- Applicant / Sponsor: Somatex Medical Technologies GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2021-02-18
Classification & Regulation
This clearance is catalogued under FDA product code NEU and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.