Picocaremajesty

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 Picocaremajesty.

Pre-market Notification Details

Device IDK212127
510k NumberK212127
Device Name:Picocaremajesty
ClassificationPowered Laser Surgical Instrument
Applicant Won Tech Co., Ltd. 64 Techno 8-ro Yuseong-gu,  KR 34028
ContactHyun Sik Yoon
CorrespondentHyun Sik Yoon
Won Tech Co., Ltd. 64 Techno 8-ro Yuseong-gu,  KR 34028
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-07
Decision Date2022-01-07

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