V-Laser

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 V-laser.

Pre-market Notification Details

Device IDK221427
510k NumberK221427
Device Name:V-Laser
ClassificationPowered Laser Surgical Instrument
Applicant WON TECH Co., Ltd. 64 Techno 8-ro, Yuseong-Gu Daejeon,  KR 34028
ContactHyun Sik Yoon
CorrespondentHyun Sik Yoon
WON TECH Co., Ltd. 64 Techno 8-ro, Yuseong-Gu Daejeon,  KR 34028
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-16
Decision Date2022-08-24

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