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510(k) Data Aggregation
K Number
K052647Device Name
CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.
Manufacturer
Date Cleared
2005-11-09
(44 days)
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN SPINE CENTER, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Device Description
The Clini-Lase System consists of a clinical and portable control base unit, and seperate attachment infrared heat lamp probes. The control base unit houses the electronics, LCD display and system controls and is powered by 12 Volts DC suplied by an AC-DC Power Adapter. The attachment probes produce infrared radiation to provide topical heating. Various single and cluster probes are available for the base units. The probes are conected by a readily replacable independent cable assembly.
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