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510(k) Data Aggregation
K Number
K123177Device Name
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
Manufacturer
Date Cleared
2013-07-03
(267 days)
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LASERSTIM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Heat Lamp Therapy Feature: The StimLase 2000 System is intended to be used for topical heating of tissue for the purpose of temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasms. The unit may be used for temporary increase in local blood circulation and/or the temporary relaxation of muscles. Electrotherapy Feature: The StimLase 2000 System is intended to be used for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Device Description
The StimLase 2000 System is a therapeutic heating device with the capability to provide simultaneous or separate electrotherapy. The system consists of a console with selector settings, a footpedal control, and a laser wand. The unit can also accommodate two disposable OEM carbon electrodes for electrical stimulation therapy.
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