(74 days)
The DermaPal, hand-held phototherapy device, is a medical ultraviolet lamp, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The DermaPal, hand-held phototherapy device, is intended for use on all skin types (I - V).
The DermaPal is a hand-held phototherapy device, which is a medical ultraviolet lamp.
The provided document is a 510(k) clearance letter from the FDA for the DermaPal device. It confirms the device's substantial equivalence to a legally marketed predicate device.
This document DOES NOT contain information regarding:
- Detailed acceptance criteria and reported device performance.
- Specific studies proving the device meets acceptance criteria.
- Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for training or testing.
- The sample size for any training set.
The letter explicitly states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the device's performance was compared to existing, cleared devices, and found to be similar enough that new detailed performance studies were not required for this 510(k) clearance.
Therefore, I cannot provide the requested information based on the text provided.
§ 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.