SANDRO Dual

Powered Laser Surgical Instrument

WON TECH Co., Ltd.

The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for Sandro Dual.

Pre-market Notification Details

Device IDK200110
510k NumberK200110
Device Name:SANDRO Dual
ClassificationPowered Laser Surgical Instrument
Applicant WON TECH Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon,  KR 34028
ContactLana Hong
CorrespondentLana Hong
WON TECH Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon,  KR 34028
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-17
Decision Date2020-03-16

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