(300 days)
These are fluorescent lamps that are designed to produce ultraviolet radiation in the UV-A range. They are not marketed with any additional components or accessories and are to be installed in fixtures designed for treatment of dermatological conditions. The intended function of these UV-A ultraviolet lamps is to be installed in the appropriate devices used for therapy for various skin related disorders.
Philips UVA Lamp
I am sorry, but the provided text is a 510(k) premarket notification FDA letter regarding a Philips UVA Lamp. It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria, as it is a regulatory document and not a scientific study report. Therefore, I cannot extract the requested details from this input.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.