(114 days)
The 3B Laser Needle is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Not Found
I am sorry, but based on the provided document, I cannot answer the request as it does not contain information about the acceptance criteria or a study proving that the device meets them. This document is an FDA 510(k) clearance letter for the 3B Laser Needle, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information, indications for use, and general controls, but it does not detail specific performance metrics, clinical study design, or results.
§ 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.