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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 K103501
Device Name ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
Applicant
ALMA LASERS, INC.
485 HALF DAY RD.
SUITE #100
BUFFALO GROVE,  IL  60089
Applicant Contact TATIANA EPSTEIN
Correspondent
ALMA LASERS, INC.
485 HALF DAY RD.
SUITE #100
BUFFALO GROVE,  IL  60089
Correspondent Contact TATIANA EPSTEIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/29/2010
Decision Date 01/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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