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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 K033549
Device Name STARLUX PULSED LIGHT SYSTEM
Applicant
PALOMAR MEDICAL PRODUCTS, INC.
82 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Applicant Contact Marcy Moore
Correspondent
PALOMAR MEDICAL PRODUCTS, INC.
82 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Correspondent Contact Marcy Moore
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/12/2003
Decision Date 03/10/2004
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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