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FDA 510(k) Application Details - K081704
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K081704
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
TINA MAYER
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
06/17/2008
Decision Date
09/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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