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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 K120622
Device Name PALOMAR VECTUS LASER
Applicant
PALOMAR MEDICAL TECHNOLOGIES, INC.
15 network dr
burlington,  MA  01803
Contact sharon timberlake
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/01/2012
Decision Date 05/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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