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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 K041086
Device Name PALOMAR STARLUX PULSED LIGHT SYSTEM
Applicant
Palomar Medical Products, Inc.
131 Kelekent Ln.
Cary,  NC  27511
Applicant Contact Marcy Moore
Correspondent
Palomar Medical Products, Inc.
131 Kelekent Ln.
Cary,  NC  27511
Correspondent Contact Marcy Moore
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/26/2004
Decision Date 01/13/2005
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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