Search Results
Found 1 results
510(k) Data Aggregation
K Number
K151521Device Name
Phoenix Thera-Lase System
Manufacturer
Date Cleared
2015-09-04
(91 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
PHOENIX THERA-LASE SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Device Description
The Phoenix Thera-Lase System is a stand-alone, solid-state class IV laser system specifically designed to provide efficient, high-power laser output with air-cooling and an output wavelength of 1060 nm. The laser output provides a 0.75-1.88 inch diameter spot to provide non-contact laser output to patients. The laser system has three different operation modes: Continuous wave, Single, and Repeat mode.
The Laser system consists of three main components: Laser Diode Module, Remote Controller, and Fiber Optic delivery cable with hand piece. The Laser Diode Module contains the power supply system and the laser diode. The Remote Controller controls the laser module through a touch screen activated control panel. The Fiber Optic delivery cable is connected to the Laser Diode Module to provide a route for administration of the laser output.
Ask a Question
Ask a specific question about this device
Page 1 of 1