Light Based Over The Counter Wrinkle Reduction

Premier North America Inc.

The following data is part of a premarket notification filed by Premier North America Inc. with the FDA for Eneo Totale (model: Eneot947).

Pre-market Notification Details

Device IDK213841
510k NumberK213841
Device Name:ENEO TOTALE (Model: ENEOT947)
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant Premier North America Inc. 3301 SW 42nd Street Ft Lauderdale,  FL  33312
ContactEllis Tamari
CorrespondentDoris Dong
Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai,  CN 201613
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-09
Decision Date2022-01-06

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