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510(k) Data Aggregation
K Number
K070021Device Name
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
Manufacturer
Date Cleared
2007-12-07
(338 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
JG MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ITALITE tm Light Wand is indicated for illumination during joint examinations, arthroscopies, biopsies, in minimally invasive procedures of the knee, shoulder, temporal-mandibular joint, ankle, and elbow.
The ITALITE tm Light Wand is disposable, single use and is intended to be discarded after the procedure. It is supplied clean but not sterile and must be sterilized before use.
The ITALITE tm is for illumination only and is not indicated for viewing. It is to be used by physicians only.
Device Description
The ITALITE tm models of Light Wands range in size as follows:
MODEL | LENGTH | DIAMETER
---------|--------|----------
650-3.1 | 650 mm | 3.1 mm
600-3.1 | 600 mm | 3.1 mm
550-3.1 | 550 mm | 3.1 mm
500-3.1 | 500 mm | 3.1 mm
450-2.0 | 450 mm | 2.0 mm
400-2.0 | 400 mm | 2.0 mm
The ITALITE tm series of Light Wands are semi rigid type devices which are intended for illumination during joint examinations, biopsies, in minimally invasive procedures of the knee, shoulder, temporal mandibular joint, ankle, and elbow.
The device consists of a thin walled stainless steel tube (either 3.1 mm or 2.0 mm) varying in length from 400 to 650 mm depending on the model number as above. 50 micron glass fibers fill the inner diameter of the tube. At the proximal end the fibers are sealed with epoxy and polished. They are terminated in a light pipe connector compatible with off the shelf light sources such as those manufactured by ACMI, Wolff, Stortz, and Olympus. A stainless steel knob at the proximal end facilitates the direction and placement of the Light Wand.
The distal end of the Light Wand has a window perpendicular to the shaft where the fibers terminate. They are epoxied and polished to form a window perpendicular to the shaft. Hence the light is directed perpendicular to the shaft and provides illumination in that direction instead of head on from the end of the Light Wand.
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