Nutra Face Lift Model PE8050

FDA 510(k) K150826 · Nutra Luxe MD, LLC

Substantially Equivalent

510(k) numberK150826

Submission

Device name
Nutra Face Lift Model PE8050
Applicant
Nutra Luxe MD, LLC
Fort Myers, FL, US
Received
March 30, 2015
Decision date
February 10, 2016
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 Nutra Face Lift Model PE8050 cleared by the FDA?

Nutra Face Lift Model PE8050 (K150826) received a 510(k) decision of Substantially Equivalent on February 10, 2016, 317 days after the submission was received.

What is the product code of K150826?

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