(468 days)
Product Code ILY - 810 and 980 nm wavelength:
The SIRONA 100 Therapy Laser System emits energy in the visible and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
Product Code PDZ - 980 nm wavelength:
The SIRONA 100 Therapy Laser System is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophyton rubrum and T. mentagrophytes, and/ or yeasts Candida albicans, etc.
Not Found
This FDA 510(k) clearance letter for the "SIRONA 100 Therapy Laser System" does not contain specific details about acceptance criteria or a study proving that the device meets those criteria.
FDA 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy or safety claims (unless specifically requested by FDA for certain types of devices).
Therefore, I cannot provide the requested information based on the provided document. The letter acknowledges the submission and states that the device is substantially equivalent to predicate devices, allowing it to be marketed. It does not detail the technical performance or the specifics of any studies used to validate performance against pre-defined acceptance criteria.
To get this information, one would typically need to refer to the actual 510(k) submission (if it were publicly available in more detail than this clearance letter) or directly contact the manufacturer.
§ 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.