Clearance Summary
ILED received FDA 510(k) clearance under submission number K061317, sponsored by Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg. 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 2006-06-22.
- Submission: K061317
- Applicant / Sponsor: Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2006-06-22
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.