Cleared Traditional

BEAR 2 Body

K232242 · Foreo, Inc. · Neurology
May 2024
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K232242 is an FDA 510(k) clearance for the BEAR 2 Body, a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Foreo, Inc. (Las Vegas, US). The FDA issued a Cleared decision on May 13, 2024, 290 days after receiving the submission on July 28, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K232242 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2023
Decision Date May 13, 2024
Days to Decision 290 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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