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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 K170269
Device Name Hee HR Mini
Applicant
Oriental Inspiration Limited
Unit 607, The Lakeside 2, W. Wing, # 10
Science Park W. Ave.
Hong Kong,  CN
Applicant Contact Andy Wu
Correspondent
Oriental Inspiration Limited
Unit 607, The Lakeside 2, W. Wing, # 10
Science Park W. Ave.
Hong Kong,  CN
Correspondent Contact Andy Wu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received01/27/2017
Decision Date 05/03/2017
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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