Avologie Scientific Eneo Totalé - The ultimate skin rejuvenation device!

Avologie Scientific Eneo Totalé - The ultimate skin rejuvenation device!

€3.995,00 €4.995,00

 

The ultimate second-generation skin rejuvenation device!

Made with innovative anti-aging technology developed by a Nobel prize-winning scientist. The ENEO TOTALÉ delivers and reveals smoother, more radiant-looking skin.

ENEO TOTALÉ is a dermatology-recommended, clinically tested red and near-infrared LED photobiomodulation device that is FDA 510(k)-cleared under K213841 for over-the-counter wrinkle reduction.


Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K213841
Device Name ENEO TOTALE (Model: ENEOT947)
Applicant
Premier North America, Inc.
3301 SW 42nd St.
Fort Lauderdale,  FL  33312
Applicant Contact Ellis Tamari
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number 878.4810
Classification Product Code
OHS  
Date Received 12/09/2021
Decision Date 01/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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