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The Excalibur IV Light Therapy System 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 pair of musculoskeletal origin.

The Excalibur IV Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of four laser diodes in one applicator head. 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 and a permanently attached applicator head. The laser operates at a measured wavelength of 635nm (±1%) and complies with all performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International Inc. is a registered laser manufacturer with the Food and Drug Administration. The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergent beam and is classified as a Class IIIa laser.

The Excalibur Light Therapy System 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 i of musculoskeletal origin.

The Excalibur Light Therapy System is a band-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of two laser diodes in one applicator head. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) cleared. The system consists of a basic hand-held, battery operated control unit and a permanently attached applicator head. The laser operates at a measured wavelength of 635mm (±1%) and complies with all performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International, Inc. is a registered laser manufacturer with the Food and Drug Administration. The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergent beam and is classified as a Class IIIa laser.

The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system. The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit. The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500. The two laser applicator heads produce an output power of <Smw prom-convergent beam and I he two laser apprication neads produced wavelength of 635mm 11% and ontinued of themse are classified as Class IIIa lastis. Bour operate and included on tortly in 21CFR Part 1040. Stargeton tional, Inc. has filed as a registered laser manufacturer with the Food and Drug Administration. The distinct LED applicator head produces a non coherent diffuse light source. This applicator head operates at a measured wavelength of 628mm ±3%.