Diamond Air+ (UI04A, UI04B, UI04C)

Light Based Over-the-counter Hair Removal

Ulike Co., Ltd

The following data is part of a premarket notification filed by Ulike Co., Ltd with the FDA for Diamond Air+ (ui04a, Ui04b, Ui04c).

Pre-market Notification Details

Device IDK221553
510k NumberK221553
Device Name:Diamond Air+ (UI04A, UI04B, UI04C)
ClassificationLight Based Over-the-counter Hair Removal
Applicant Ulike Co., Ltd 2, Myeongdong, 6-gil, Jung-gu Seoul,  KR 04535
ContactLin Xiaoming
CorrespondentSun Cindy
PureVision Ai, Inc. 111 Town Square Place, Suite 1203 New Jersey,  NJ  07310
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-31
Decision Date2022-09-15

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