(186 days)
The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.
Not Found
I apologize, but the provided FDA 510(k) clearance letter for the Préime DermaFacial (MicroT) device does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.
This type of FDA clearance letter primarily states that the device has been found substantially equivalent to a predicate device and outlines regulatory obligations. It does not typically detail the specific performance studies, acceptance criteria, or expert qualifications that were submitted as part of the 510(k) application.
To answer your questions, I would need to access the full 510(k) submission document or a summary of safety and effectiveness, which is not included in the provided text.
Therefore, I cannot provide the requested table and detailed information based solely on this document.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).