Infrared Light Therapy Led Facial Light Therapy Mask-Derma Plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine

Light Based Over The Counter Wrinkle Reduction

Ningbo Hesi Electric Co., Ltd

The following data is part of a premarket notification filed by Ningbo Hesi Electric Co., Ltd with the FDA for Infrared Light Therapy Led Facial Light Therapy Mask-derma Plus, Photons Facial Skin Care Machine Led Beauty Mask Therapy Beauty Machine.

Pre-market Notification Details

Device IDK200983
510k NumberK200983
Device Name:Infrared Light Therapy Led Facial Light Therapy Mask-Derma Plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant Ningbo Hesi Electric Co., Ltd No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict, Ningbo, Zhejiang, Ningbo,  CN 315000
ContactMa Lulu
CorrespondentCassie Lee
Guangzhou GLOOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzh Guangzhou,  CN 511495
Product CodeOHS  
Subsequent Product CodeILY
Subsequent Product CodeOLP
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-14
Decision Date2021-07-14

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