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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 K061720
Device Name COSMELIGHT
Applicant
Penntack Enterprises, Inc.
3321 NW 79th St.
Miami,  FL  33147
Applicant Contact PABLO PENA
Correspondent
Penntack Enterprises, Inc.
3321 NW 79th St.
Miami,  FL  33147
Correspondent Contact PABLO PENA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/19/2006
Decision Date 01/31/2007
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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