# K091246: Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)

- Pathway: 510(k) (Abbreviated)
- Applicant: Trumpf Medizin Systeme GmbH + Co. KG
- Decided: Sep 28, 2009 after 154 days
- Product code: FSS (Light, Surgical, Floor Standing)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K965130 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061317: ILED, Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg (2006) Summary page 2.
- K011693: Trumpf Surgical Lights, Models 301,501,701,1001, Trumpf Medical Systems, Inc. (2001) Summary page 2.

## Indications for use
The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".

Source page: https://510kreport.com/device/K091246
Methodology: https://510kreport.com/methodology