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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name over-the-counter powered light based laser for acne
510(k) Number K170260
Device Name BC-001+ Acne Purifier
Applicant
Oriental Inspiration Limited
Unit 607, The Lakeside 2, West Wing, No. 10
Science Park West Avenue
Hong Kong,  CN
Applicant Contact Andy Wu
Correspondent
Oriental Inspiration Limited
Unit 607, The Lakeside 2, West Wing, No. 10
Science Park West Avenue
Hong Kong,  CN
Correspondent Contact Andy Wu
Regulation Number878.4810
Classification Product Code
OLP  
Date Received01/27/2017
Decision Date 04/25/2017
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
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