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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 K080244
Device Name PALOMAR LUX 1540 HANDPIECE
Applicant
PALOMAR MEDICAL PRODUCTS, INC.
82 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Applicant Contact Sharon Timberlake
Correspondent
PALOMAR MEDICAL PRODUCTS, INC.
82 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Correspondent Contact Sharon Timberlake
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/31/2008
Decision Date 06/20/2008
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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