(66 days)
For the removal of hair
The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
Information regarding device acceptance criteria and studies are not available in the provided text. The document is a 510(k) summary and FDA clearance letter for the Feminique™ Sonic Hair Remover. It establishes substantial equivalence to a predicate device (IGIÁ Hair Removal System) based on similar technology (radio frequency energy for hair removal) and output (radio frequency signal characteristics). However, it does not include details on specific performance acceptance criteria or a study demonstrating the device meets such criteria.
The 510(k) summary mentions that "The safety and efficacy of tweezer-type epilators are discussed in the attached Federal Register notice published by the Food and Drug Administration (FDA) on June 11, 1997, 62 Fed. Reg. 31771-775." This suggests that the general safety and efficacy of this type of device have been established by the FDA, and the Feminique™ device is considered safe and effective because it is substantially equivalent to a device already deemed so. However, the specific study details for the Feminique™ device itself are not provided in the given text.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert qualifications, or study methodologies based on the provided document.
§ 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.