(270 days)
The Del Sol Red Light Therapy System is intended to emit energy in the near infrared spectrum (880nm) to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
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I am sorry, but the document provided does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a red light therapy system, and it primarily focuses on the regulatory aspects of the device, such as its substantial equivalence to a predicate device and its intended use. It does not include details about device performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically found in clinical study reports or detailed technical documentation.
§ 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.