(321 days)
The LEP2000 Photonic Therapy System is a device that emits energy in the infrared spectrum and is indicated for adjunctive use in providing temporary relief joint pain.
The LEP2000 Photonic Therapy System is a device that emits energy in the infrared spectrum.
This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for the LEP 2000 Photonic Therapy System. It describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets them.
Therefore, I cannot provide the requested information based on this document. The document confirms the device is substantially equivalent to a predicate device, which allows it to be marketed, but does not detail the specific performance testing you're asking about.
§ 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.