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510(k) Data Aggregation
K Number
K080962Device Name
LITE WAND II
Manufacturer
THOMPSON SURGICAL INSTRUMENTS, INC.
Date Cleared
2008-06-25
(82 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
THOMPSON SURGICAL INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. It is intended to be used with ACMI, Storz, Wolf, or Olympus connector cables. The Lite Wand II is intended to be used by surgeons and medical care practitioners in a surgical setting.
Device Description
Thompson Surgical Instruments, Inc. Lite Wand II is a fiber optic surgical light designed to provide visible illumination of the surgical field or the patient. The Lite Wand II consists of a Cam Joint fixture which attaches the device to a retractor system arm, a flexible "gooseneck" supported lighthead for easy positioning, and a fiber optic bundle. The Thompson surgical Lite Wand II is designed as a task light for surgical use.
The Lite Wand II is designed to be a replacement or substitute for headlamps and it uses the same technology currently used in other headlamps and light sources. These other devices have similar performance characteristics which have been previously cleared by the FDA.
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