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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
Applicant
ALMA LASERS INC.
485 HALF DAY RD.
SUITW NO. 100
BUFFALO GROVE,  IL  60089
Applicant Contact KATHY MAYNOR
Correspondent
ALMA LASERS INC.
485 HALF DAY RD.
SUITW NO. 100
BUFFALO GROVE,  IL  60089
Correspondent Contact KATHY MAYNOR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/16/2012
Decision Date 09/21/2012
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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