Clearance Summary
Forma System, Forma Light System received FDA 510(k) clearance under submission number K160195, sponsored by Formatk Systems , Ltd.. 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 2016-04-15.
- Submission: K160195
- Applicant / Sponsor: Formatk Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2016-04-15
Classification & Regulation
This clearance is catalogued under FDA product code ONF and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.