(32 days)
The MLS-AC Derma Scanner™ is indicated while using the red diodes for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, and while using the blue diode, to treat moderate inflammatory Acne Vulgaris.
Not Found
The provided document is an FDA 510(k) clearance letter for the MLS-AC Derma Scanner™, and it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter from the FDA states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. This substantial equivalence is typically established by demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information from this document. To answer your questions, one would need access to the actual 510(k) submission and the studies referenced within it, which are not included in the provided text.
§ 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.