UV Radiation Treatment System

Light, Ultraviolet, Dermatological

Xuzhou Yongkang Electronic Science Technology Co., Ltd

The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Uv Radiation Treatment System.

Pre-market Notification Details

Device IDK191571
510k NumberK191571
Device Name:UV Radiation Treatment System
ClassificationLight, Ultraviolet, Dermatological
Applicant Xuzhou Yongkang Electronic Science Technology Co., Ltd 4F Building C8, 40 Jingshan Road, Economic And Technological Development Zone Xuzhou,  CN 221000
ContactKai Li
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-14
Decision Date2020-02-06

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.