About This 510(k) Submission
K091246 is an FDA 510(k) clearance for the ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M), a Light, Surgical, Floor Standing (Class II — Special Controls, product code FSS), submitted by Trumpf Medizin Systeme GmbH + Co. KG (Charleston, US). The FDA issued a Cleared decision on September 28, 2009, 154 days after receiving the submission on April 27, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.