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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 K181734
Device Name Beurer IPL 8500 device/ IPL VelvetSkin Pro
Applicant
Home Well Trading, Ltd.
Omar Hodge Bldg., Rd. Town
Tortola,  VG
Applicant Contact Martin Gurovich
Correspondent
Home Well Trading, Ltd.
Omar Hodge Bldg., Rd. Town
Tortola,  VG
Correspondent Contact Martin Gurovich
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received07/02/2018
Decision Date 09/19/2018
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
Predetermined Change
Control Plan Authorized		 No
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