# K083710: Retractor Lite

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Surgical Instruments, Inc.
- Decided: Feb 23, 2009 after 70 days
- Product code: FST (Light, Surgical, Fiberoptic)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Thompson Surgical Instruments, Inc. Retractor Lite intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor blade which it can attach to through the use of TECASONTM P XRO clips. The Retractor Lite is designed to provide visible illumination of the surgical field or the patient through a Xenon light source only. The Retractor Lite is designed to be used by surgeons and other medical care practitioners in a surgical setting.

Source page: https://510kreport.com/device/K083710
Methodology: https://510kreport.com/methodology