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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K170970
Device Name Epilaser
Applicant
Epilady 2000, LLC
3 Hacharash St. Ind. Zone
Hazor Haglilit,  IL 1035102
Applicant Contact Joseph Miller
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact John J. Smith
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/31/2017
Decision Date 09/01/2017
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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