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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Booth, Sun Tan
510(k) Number K161394
Device Name HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Applicant
Sportarredo Group S.C.
Via Dell' Industria 7
Gruaro,  IT 30020
Applicant Contact STEFANO IRIDIO
Correspondent
Registrar Corp.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact Lara Luzak
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received05/19/2016
Decision Date 07/06/2017
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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