(189 days)
The RJ Low Level Laser are intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthrilis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.
RJ Low Level Laser Family
The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication), or MRMC comparative effectiveness studies for the "LaserPen® Expert" or related devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on FDA's determination of substantial equivalence to a predicate device and regulatory compliance.
§ 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.