(473 days)
Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
Palm NRG cellulite body device (model: Palm NRG body device)
This FDA 510(k) clearance letter for the "Palm NRG cellulite body device" indicates that the device is substantially equivalent to a legally marketed predicate device. However, the provided document does not contain any information regarding acceptance criteria, the study proving the device meets these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The letter focuses on regulatory compliance, outlining the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and other relevant regulations. It confirms the device's classification and lists the indications for use.
Therefore, I cannot provide the requested information based on the given input document. The document simply states the intended use of the device: "Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite." The specifics of how this claim was substantiated through studies are not present in this regulatory clearance letter.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.