CO2 Laser 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 Co2 Laser Therapy System.

Pre-market Notification Details

Device IDK201109
510k NumberK201109
Device Name:CO2 Laser 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
CorrespondentShelley Li
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 Received2020-04-27
Decision Date2020-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000
06970745914129 K201109 000
06970745914112 K201109 000

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