(91 days)
The VelasII Therapy Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Not Found
The provided text is a 510(k) premarket notification approval letter for the VelasII Therapy Laser System. It does not contain any information about acceptance criteria or supporting studies that demonstrate the device meets these criteria.
Therefore, I cannot provide the requested information. The document focuses on the regulatory approval process based on substantial equivalence to a predicate device, rather than detailed performance study 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.