(340 days)
The QLaser System is indicated for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional.
Not Found
The provided text is an FDA 510(k) clearance letter for the QLaser System, classifying it as an infrared lamp. It contains information about the device's regulatory status, indications for use, and general responsibilities under the Act. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, which are typically found in the 510(k) submission summary or associated documents, but not in the clearance letter itself. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves 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.