(76 days)
The Intended use for this product is to remove unwanted hair.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Dapelle™ Hair Remover." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and classification, not on the detailed technical or clinical performance evaluation of the device.
§ 878.5360 Tweezer-type epilator.
(a)
Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.(b)
Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.