(111 days)
The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Scalar Wave Laser System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter is primarily concerned with establishing "substantial equivalence" of the Scalar Wave Laser System to a predicate device, which is a regulatory pathway for certain medical devices. It confirms that the device can be marketed in the US, subject to general controls and FDA regulations.
Therefore, I cannot provide the requested information based on the input text. The questions you've asked are typically addressed in a clinical study report or a 510(k) submission's performance data section, not in the FDA's clearance letter itself.
§ 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.