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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 With Microbeam\Fractional Output
510(k) Number K103664
Device Name PRIMUS AESTHETIC PLATFORM
Applicant
Palomar Medical Technologies, Inc.
15 Network Dr.
Burlington,  MA  01803
Applicant Contact Sharon Timberlake
Correspondent
Palomar Medical Technologies, Inc.
15 Network Dr.
Burlington,  MA  01803
Correspondent Contact Sharon Timberlake
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received12/16/2010
Decision Date 03/17/2011
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
Predetermined Change
Control Plan Authorized		 No
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