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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 Wrinkle Reduction
510(k) Number K161849
Device Name Bright
Applicant
Tanda Beauty Canada, Inc.
11-380 Jamieson Pkwy.
Cambridge,  CA
Applicant Contact Bobae Kim
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4810
Classification Product Code
OHS  
Date Received07/05/2016
Decision Date 07/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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