Diode Laser Body Sculpture System

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

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 Diode Laser Body Sculpture System.

Pre-market Notification Details

Device IDK201731
510k NumberK201731
Device Name:Diode Laser Body Sculpture System
ClassificationLaser For Disruption Of Adipocyte Cells For Aesthetic Use
Applicant Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai,  CN 200231
ContactFelix Li
CorrespondentFelix Li
Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai,  CN 200231
Product CodePKT  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-24
Decision Date2020-09-10

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