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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K181568
Device Name IPL Salon Hair Reduction System
Applicant
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
4th Floor Of Bldg. #1, #228, Jiaosong Rd.
Taiwanese Investment Zone
Zhangzhou,  CN
Applicant Contact Bruce Wu
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
108 Kezhu Rd.
Scientech Park Guangzhou Economic & Technology Dept.
Guangzhou,  CN
Correspondent Contact Iris Fung
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/14/2018
Decision Date 09/11/2018
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
Predetermined Change
Control Plan Authorized		 No
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