(76 days)
The Erchonia® PL Touch laser is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Erchonia® PL-Touch laser. It confirms that the device is substantially equivalent to legally marketed predicate devices for the indicated use of temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
However, this document does not contain information on the acceptance criteria, specific device performance data from a study, sample sizes, expert qualifications, adjudication methods, or ground truth details as requested. The letter is an administrative clearance document and does not include the technical study details typically found in a clinical trial report or a summary of safety and effectiveness (SSE).
Therefore, I cannot provide the requested table and information based on the given input.
§ 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.