Cleared Traditional

K102494 - THE BUZZ FACIAL TONING SYSTEM

K102494 is an FDA 510(k) clearance for THE BUZZ FACIAL TONING SYSTEM, manufactured by Daka International , Ltd.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 465-day FDA review.

K102494 · Daka International , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
465d
Days
Class 2
Risk

K102494 is an FDA 510(k) clearance for the THE BUZZ FACIAL TONING SYSTEM. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Daka International , Ltd. (Knoxville, US). The FDA issued a Cleared decision on December 9, 2011 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K102494

510(k) Number K102494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2010
Decision Date December 09, 2011
Days to Decision 465 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
316d slower than avg
Panel avg: 149d · This submission: 465d
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 80
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K102494.
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K071573 · Fatrotek S.R.L. · Dec 2008
K102494 · THE BUZZ FACIAL TONING SYSTEM
Download PDF FDA Summary Daka International , …