Trinity ELE Plus and Trinity ELE Plus Pro— 510(k) K201906

Name: FDA 510(k) clearance K201906
Creator: U.S. Food and Drug Administration
Published: 2021-02-24

Substantially Equivalent

Carol Cole Company Dba Nuface

FDA 510(k) clearance K201906 for Trinity ELE Plus and Trinity ELE Plus Pro, Substantially Equivalent on 2021-02-24. Applicant: Carol Cole Company Dba Nuface. Device class: 2.

Clearance details

Applicant: Carol Cole Company Dba Nuface
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2020-07-09
Decision date: 2021-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.