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FDA 510(k) Application Details - K110349
Device Classification Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
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510(K) Number
K110349
Device Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD.
HAYWARD, CA 94545 US
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Contact
KRISTINE FOSS
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Regulation Number
878.4810
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Classification Product Code
ONG
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More FDA Info for this Product Code
Date Received
02/07/2011
Decision Date
05/03/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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