Cleared Traditional

K244004 - Microcurrent Facial Device (CEC101

K244004 is an FDA 510(k) clearance for Microcurrent Facial Device (CEC101, manufactured by Shenzhen Dachi Communication Co., Ltd.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K244004 · Shenzhen Dachi Communication Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
196d
Days
Class 2
Risk

K244004 is an FDA 510(k) clearance for the Microcurrent Facial Device (CEC101, EE0101, EEI101). Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Shenzhen Dachi Communication Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 10, 2025 after a review of 196 days - an extended review cycle.

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 Shenzhen Dachi Communication Co., Ltd. devices

FDA 510(k) Submission Details - K244004

510(k) Number K244004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2024
Decision Date July 10, 2025
Days to Decision 196 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 148d · This submission: 196d
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Jilan Luo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 53
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K244004.
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