Cleared Traditional

K200803 - BEAR and BEAR mini

K200803 is an FDA 510(k) clearance for BEAR and BEAR mini, manufactured by Foreo, Inc.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K200803 · Foreo, Inc. · Neurology device
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Jul 2020
Decision
126d
Days
Class 2
Risk

K200803 is an FDA 510(k) clearance for the BEAR and BEAR mini. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Foreo, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 31, 2020 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Foreo, Inc. devices

FDA 510(k) Submission Details - K200803

510(k) Number K200803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2020
Decision Date July 31, 2020
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 53
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