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FDA 510(k) Application Details - K121515
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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510(K) Number
K121515
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD
HAYWARD, CA 94545 US
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Contact
KRISTINE FOSS
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
ONF
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More FDA Info for this Product Code
Date Received
05/22/2012
Decision Date
06/05/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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