(103 days)
The Omnilux Plus is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and temporarily increase local blood circulation where applied.
The Omnilux Plus is a near infra-red light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output wavelength is 830 ± 5 nm. The Omnilux Plus base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The user interface consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.
The provided document is a 510(k) Summary for the Omnilux Plus device, which is an infrared lamp. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices and detailing the general information and indications for use.
Therefore, I cannot provide the requested information based on the given text. The document states "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Photo Therapeutics Limited believes that no anges of safety or effectiveness." This statement, however, is a general assertion rather than a description of an actual study with acceptance criteria and results.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.