(3 days)
The MF SC GEN2 Facial Toning System is intended to stimulate the face. The device is intended for over the counter cosmetic use.
Not Found
The provided document is an FDA 510(k) clearance letter for the "MF SC GEN2 Facial Toning System." It confirms the device's substantial equivalence to legally marketed predicate devices for its stated indications for use.
Crucially, the document does NOT contain any information regarding acceptance criteria or a study proving the device meets these criteria.
This type of FDA letter is primarily a regulatory approval and does not detail the clinical or performance study data that the manufacturer submitted to support their 510(k) application. To provide the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.), one would need access to the actual 510(k) submission document itself, which is typically confidential business information and not released publicly by the FDA in detail.
Therefore,Based on the information provided in the FDA 510(k) clearance letter (K252218), it is not possible to describe the acceptance criteria and the study that proves the device meets these criteria.
The clearance letter primarily states that the device, "MF SC GEN2 Facial Toning System," is substantially equivalent to legally marketed predicate devices for its intended use (to stimulate the face, for over-the-counter cosmetic use). It does not contain the detailed performance data, study design, or acceptance criteria that would have been part of the manufacturer's 510(k) submission.
All sections of your request cannot be fulfilled as the necessary information is not present in the provided document.
To provide the requested details, one would need access to the full 510(k) submission document from Micro Current Technology, Inc., which is not publicly available in this correspondence.
§ 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).