(180 days)
For Infrared Lamp (Laser)
Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect XT) Laser Transportable Systems are indicated for topical heating for:
- temporary increase in local blood circulation
- temporary relief of minor muscle and joint aches, pains and stiffness
- relaxation of muscles
- temporary relief of muscle spasms
- temporary relief of minor pain and stiffness associated with arthritis
Vectra Genisys Laser System (Intelect XT Laser System)
I am sorry, but based on the provided documents, I cannot answer your request. The documents are a 510(k) clearance letter from the FDA for a medical device (Vectra Genisys Laser System) and its indications for use. They do not contain information about acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.
These documents primarily confirm that the device is substantially equivalent to a legally marketed predicate device and outline its approved indications for use. They do not describe the specific testing and validation studies typically required to demonstrate performance against acceptance criteria in the way your request specifies.
§ 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.