BEAR and BEAR mini

• K Number: K200803
• Device Name: BEAR and BEAR mini
• Manufacturer: FOREO, Inc.
• Date Cleared: 2020-07-31 ( 126 days)
• Product Code: NFO
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 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).