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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 K052371
Device Name DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
Applicant
Hair International Systems USA, Inc.
4590 Macarther Blvd., Suite 500
Newport Beach,  CA  92692 -2028
Applicant Contact CRAIG A MITCHELL
Correspondent
Hair International Systems USA, Inc.
4590 Macarther Blvd., Suite 500
Newport Beach,  CA  92692 -2028
Correspondent Contact CRAIG A MITCHELL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/30/2005
Decision Date 05/04/2006
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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