Picocare

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 Picocare.

Pre-market Notification Details

Device IDK162755
510k NumberK162755
Device Name:Picocare
ClassificationPowered Laser Surgical Instrument
Applicant WON TECH CO., LTD. 64, Techno 8-ro, Yuseong-gu Daejeon,  KR 305-500
ContactJames Hoon Lim
CorrespondentJames Hoon Lim
WON TECH CO., LTD. 64, Techno 8-ro, Yuseong-gu Daejeon,  KR 305-500
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-30
Decision Date2017-06-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800022303200 K162755 000

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