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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 K110907
Device Name PALOMAR ICON (TM) AESTHETIC SYSTEM
Applicant
PALOMAR MEDICAL TECHNOLOGIES, INC.
15 Network Drive
Burlington,  MA  01803
Applicant Contact Sharon Timberlake
Correspondent
PALOMAR MEDICAL TECHNOLOGIES, INC.
15 Network Drive
Burlington,  MA  01803
Correspondent Contact Sharon Timberlake
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received03/31/2011
Decision Date 06/22/2011
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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