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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 K110735
Device Name TANDA MAX OTC SYSTEM
Applicant
Pharos Life Corporation
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JOHNATHAN S KAHAN
Correspondent
Pharos Life Corporation
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JOHNATHAN S KAHAN
Regulation Number878.4810
Classification Product Code
OHS  
Date Received03/16/2011
Decision Date 08/03/2011
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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