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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K051214
Device Name ALUMA SKIN RENEWAL SYSTEM
Applicant
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Applicant Contact Connie Hoy
Correspondent
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Correspondent Contact Connie Hoy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/12/2005
Decision Date 10/24/2005
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
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