(84 days)
The MedX LCS Laser Series is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with carpal tunnel syndrome.
MedX LCS Laser Series primarily consists of a hand held portable laser device and the battery recharger. The hand held laser contains the laser diodes and assembly, circuit board, electronics, battery and labels. The power receptacle for the battery recharger is located at the base of the hand held laser.
I'm sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study breakdown. The document is primarily a 510(k) summary for the MedX LCS Laser Series, focusing on its classification, predicate device, and FDA's substantial equivalence determination.
It does not include:
- Acceptance criteria for device performance.
- Any study details, such as sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, or results of a comparative effectiveness study.
- Standalone algorithm performance.
Therefore, I cannot fulfill the request as the required information is not present in 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.