IPL Treatment Systems

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

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 Ipl Treatment Systems.

Pre-market Notification Details

Device IDK200746
510k NumberK200746
Device Name:IPL Treatment Systems
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District Shanghai,  CN 200231
ContactFelix Li
CorrespondentFelix Li
Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District Shanghai,  CN 200231
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-23
Decision Date2020-05-15

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