Oren LED Perioral Light Therapy System

Light Based Over The Counter Wrinkle Reduction

Shenzhen Kaiyan Medical Co Ltd

The following data is part of a premarket notification filed by Shenzhen Kaiyan Medical Co Ltd with the FDA for Oren Led Perioral Light Therapy System.

Pre-market Notification Details

Device IDK213024
510k NumberK213024
Device Name:Oren LED Perioral Light Therapy System
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant Shenzhen Kaiyan Medical Co Ltd 40A Fuxin Road, Fuyong Subdistrict, BaoAn District Shenzhen,  CN 518000
ContactAlain Dijkstra
CorrespondentAlain Dijkstra
Shenzhen Kaiyan Medical Co Ltd 40A Fuxin Road, Fuyong Subdistrict, BaoAn District Shenzhen,  CN 518000
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-21
Decision Date2021-12-22

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