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FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.

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The provided documents are FDA 510(k) clearance letters for the device FAQ 101. These letters indicate that the device has received substantial equivalence determination, allowing it to be marketed. However, these documents do not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

The letters primarily focus on:

• Notifying the applicant (Foreo, Inc.) of the substantial equivalence determination for the FAQ 101 device.
• Listing the regulation number, regulation name, regulatory class, and product codes.
• Providing administrative updates (like adding a product code).
• Stating the general controls provisions of the Act that apply to the device.
• Listing the Indications for Use for the device: "FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI."

Therefore, I cannot provide the requested information based on the given input. To answer your questions, I would need a different type of document, such as a study report, clinical trial summary, or a more detailed section of the 510(k) submission that outlines the performance testing and acceptance criteria.

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