The Buzz Facial Toning System

FDA 510(k) K102494 · Daka International , Ltd.

Substantially Equivalent

510(k) numberK102494

Submission

Device name
The Buzz Facial Toning System
Applicant
Daka International , Ltd.
Knoxville, TN, US
Received
August 31, 2010
Decision date
December 9, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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Questions and answers

When was The Buzz Facial Toning System cleared by the FDA?

The Buzz Facial Toning System (K102494) received a 510(k) decision of Substantially Equivalent on December 9, 2011, 465 days after the submission was received.

What is the product code of K102494?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.