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The GRT LITE Model PRO-8A is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for: - -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. - -- Adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS).

The Model PRO-8A is a hand-held, non-invasive, pain therapy system which utilizes four nonheating light emitting diodes (LED) consisting of two visible LED's and two infrared LED's in one system. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) approved. The system consists of a basic hand-held, battery operated, control unit with the four LED's emitting light through a special red acrylic lens which does not absorb any light transmission. The visible LEDs operate at a measured wavelength of 628nm (±5%) and the infrared LEDs operate at a measured wavelength of 850nm (±5%).