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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 K082247
Device Name EVIS MD PLATINUM RED LIGHT THERAPY
Applicant
Ageless Beauty Corporation
675 Pine St.
Elgin,  IL  60123
Applicant Contact JILL CREASY
Correspondent
Ageless Beauty Corporation
675 Pine St.
Elgin,  IL  60123
Correspondent Contact JILL CREASY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/08/2008
Decision Date 10/08/2008
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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