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FDA 510(k) Application Details - K111213
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K111213
Device Name
Powered Laser Surgical Instrument
Applicant
LUMENIS INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104 US
Other 510(k) Applications for this Company
Contact
JACE R MCLANE
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2011
Decision Date
07/25/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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