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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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The BEAR and BEAR mini devices are intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the FOREO BEAR and BEAR mini devices does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria.

This document is primarily a clearance letter stating that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines:

• The device name, regulation number, and product code.
• The date of receipt and clearance.
• General controls and regulations applicable to the device.
• The Indications for Use statement.

It does not include:

• Specific acceptance criteria tables for device performance.
• Details of performance studies (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types).
• Information on training sets (sample size, ground truth establishment).

To find the information you requested, you would typically need to consult the full 510(k) submission, specifically the performance data section, which is often not publicly available in its entirety in the FDA's clearance letter database.

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