Clearance Summary
Sunrise 6200, Sunrise 7200 received FDA 510(k) clearance under submission number K173565, sponsored by Jk-Holding 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 2018-02-14.
- Submission: K173565
- Applicant / Sponsor: Jk-Holding GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 2018-02-14
Classification & Regulation
This clearance is catalogued under FDA product code LEJ and 21 CFR 878.4635, within the General, Plastic Surgery review panel as a Class II device.