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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K060839
Device Name ABC HAIR REMOVAL SYSTEM
Applicant
Palomar Medical Technologies, Inc.
82 Cambridge St.
Burlington,  MA  01803
Applicant Contact Sharon Timberlake
Correspondent
Palomar Medical Technologies, Inc.
82 Cambridge St.
Burlington,  MA  01803
Correspondent Contact Sharon Timberlake
Regulation Number878.4810
Classification Product Code
OHT  
Date Received03/28/2006
Decision Date 12/07/2006
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
Predetermined Change
Control Plan Authorized		 No
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