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510(k) Data Aggregation
K Number
K070353Device Name
KELSEY INTERSITITAL LASER THERAPY SYSTEM
Manufacturer
KELSEY, INC.
Date Cleared
2007-05-02
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
KELSEY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kelsey Interstitial Laser Therapy System is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.
Device Description
The Kelsey Interstitial Laser Therapy system consists of the following:
- One laser probe, a 14 gauge needle, 304 stainless steel with one (1) thermistor attached.
- One temperature probe, a 14 gauge needle, 304 stainless steel with five (5) thermistors attached.
- Thermistor temperature to digital converter.
- Syringe infusion pump capable of accurately infusing a normal saline solution at variable flow rates to 1 cc per minute, continuously adjustable, including bolus function.
- Laser diode source, 1-8 watts, 805 nominal nanometer wavelength.
- Storage cart.
- Personal computer running Windows XP with Service Pack 2, or better, including monitor and keyboard.
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