Hair Boom 69, Hair Boom Air, Ulike Hair UpUp

Laser, Comb, Hair

Won Tech Co., Ltd.

The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for Hair Boom 69, Hair Boom Air, Ulike Hair Upup.

Pre-market Notification Details

Device IDK192425
510k NumberK192425
Device Name:Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
ClassificationLaser, Comb, Hair
Applicant Won Tech Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon,  KR 34028
ContactJake Yu
CorrespondentJake Yu
Won Tech Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon,  KR 34028
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-05
Decision Date2019-09-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800022304924 K192425 000

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