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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 K121150
Device Name ALMA LASERS FAMILY OF PIXEL RF TIPS
Original Applicant
ALMA LASERS INC.
485 half day rd.
suitw no. 100
buffalo grove,  IL  60089
Original Contact kathy maynor
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/16/2012
Decision Date 09/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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