(112 days)
The Laser Pen is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffhess, arthritis pain, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a laser device. It confirms the substantial equivalence of the device to a predicate device and outlines regulatory requirements.
However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on 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.