308nm Excimer System

Light, Ultraviolet, Dermatological

Chongqing Peninsula Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Chongqing Peninsula Medical Technology Co., Ltd. with the FDA for 308nm Excimer System.

Pre-market Notification Details

Device IDK192642
510k NumberK192642
Device Name:308nm Excimer System
ClassificationLight, Ultraviolet, Dermatological
Applicant Chongqing Peninsula Medical Technology Co., Ltd. No.2-4, 2F Block I, Ke Yuan 4th Road, Jiulongpo District Chongqing,  CN 400041
ContactZhang Sudi
CorrespondentCassie Lee
Guangzhou GLOMED Biologcial Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou Guangzhou,  CN 510000
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2020-05-13

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