Photodynamic Therapy System

Powered Laser Surgical Instrument

Shanghai Apolo Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Shanghai Apolo Medical Technology Co., Ltd. with the FDA for Photodynamic Therapy System.

Pre-market Notification Details

Device IDK190938
510k NumberK190938
Device Name:Photodynamic Therapy System
ClassificationPowered Laser Surgical Instrument
Applicant Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A. No.388, Yindu Road, Xuhui District Shanghai,  CN 200231
ContactFelix Li
CorrespondentClaire Zhang
Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Jingan District Shanghai,  CN 200071
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-10
Decision Date2019-06-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970745917700 K190938 000
00860007876820 K190938 000

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