(127 days)
The ASA 'Mphi Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
The ASA 'Mphi Family' Diode Lasers provides 808 and 905 nm wavelengths. Laser emission activation is by the user selectable controller. Electrical requirement is 110-250VAC, 50VA, 50-60Hz, single phase or battery mode.
The provided text is a 510(k) summary for the ASA 'Mphi Family' Diode Laser. It explicitly states:
"Nonclinical Performance Data: none"
"Clinical Performance Data: none"
Therefore, there is no information within the provided document to address any of the points regarding acceptance criteria or a study proving the device meets those criteria. The submission relies entirely on demonstrating substantial equivalence to a predicate device, which had "the same indications for use, the same principle of operation, and identical performance specifications."
Conclusion:
Based on the provided K111901 document, there is no information available regarding acceptance criteria or a study demonstrating the device meets such criteria. The submission is based solely on a comparison to a predicate device, and it explicitly states that no nonclinical or clinical performance data was provided.
§ 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.