Clearance Summary
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) received FDA 510(k) clearance under submission number K091246, sponsored by Trumpf Medizin Systeme GmbH + Co. KG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-09-28.
- Submission: K091246
- Applicant / Sponsor: Trumpf Medizin Systeme GmbH + Co. KG
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2009-09-28
Classification & Regulation
This clearance is catalogued under FDA product code FSS and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.