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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K213558
Device Name IPL Hair Removal Device
Applicant
Ulike Co., Ltd
2, Myeongdong, 6-gil, Jung-gu
Seoul,  KR
Applicant Contact Lin Xiaoming
Correspondent
PureVision Ai, Inc.
111 Town Square Place, Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Bryan Wong
Regulation Number878.4810
Classification Product Code
ONF  
Date Received11/08/2021
Decision Date 03/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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