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FDA 510(k) Application Details - K123120
Device Classification Name
Ophthalmic Femtosecond Laser
More FDA Info for this Device
510(K) Number
K123120
Device Name
Ophthalmic Femtosecond Laser
Applicant
ALCON LENSX, INC.
733 BOLSANA DRIVE
LAGUNA BEACH, CA 92651 US
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Contact
JUDY GORDON, DVM
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Regulation Number
886.4390
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Classification Product Code
OOE
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More FDA Info for this Product Code
Date Received
10/03/2012
Decision Date
12/12/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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