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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 K021975
Device Name LASERSYSTEM BEAUTYSTAR 532
Applicant
Asclepion-Meditec AG
8884 Warner Ave.
Suite 167
Fountian Valley,  CA  92708
Applicant Contact WILLIAM KELLY
Correspondent
Asclepion-Meditec AG
8884 Warner Ave.
Suite 167
Fountian Valley,  CA  92708
Correspondent Contact WILLIAM KELLY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/17/2002
Decision Date 09/13/2002
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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