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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 hair removal
510(k) Number K181121
Device Name Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
Applicant
Home Well Trading LTD
Omar Hodge Building, Road Town
Tortola,  VG 1110
Applicant Contact Martin Gurovich
Correspondent
Home Well Trading LTD
Omar Hodge Building, Road Town
Tortola,  VG 1110
Correspondent Contact Martin Gurovich
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received04/30/2018
Decision Date 06/28/2018
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
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