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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 K132613
Device Name SONILASE LIGHT THERAPY DEVICE
Applicant
Biorenew Labs, LLC
2424 Dempster Dr.
Coralville,  IA  52241
Applicant Contact SUSAN ANTHONEY
Correspondent
Biorenew Labs, LLC
2424 Dempster Dr.
Coralville,  IA  52241
Correspondent Contact SUSAN ANTHONEY
Regulation Number878.4810
Classification Product Code
OHS  
Date Received08/21/2013
Decision Date 02/05/2014
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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