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510(k) Data Aggregation
K Number
K080689Device Name
SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
Manufacturer
Date Cleared
2008-07-09
(120 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
PREMIER DYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra Therapy Spectra A1000 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Device Description
The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra A1000 is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle pain and/or the temporary relaxation of muscle.
The Spectra A1000 System houses multiple photo energy devices. The photo devices consist of 4 dual [infrared and RED visible] lasers combined with a cluster of 8 visible RED LED's, and 8 Infrared LED's and a yellow indicator lamp.
The Spectra A1000 Laser Therapy Device consists of a docking unit, a USB and laser port, a key port and a key. The laser and light therapy releases radiation with wing wavelengths, all of which fall within the infrared range as defined in 21 CFR 890.5500.
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