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FDA 510(k) Application Details - K143010
Device Classification Name
Ophthalmic Femtosecond Laser
More FDA Info for this Device
510(K) Number
K143010
Device Name
Ophthalmic Femtosecond Laser
Applicant
LENSAR, INC.
2800 DISCOVERY DRIVE
SUITE 100
ORLANDO, FL 32826 US
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Contact
MOHINDER MERCHEA
Other 510(k) Applications for this Contact
Regulation Number
886.4390
More FDA Info for this Regulation Number
Classification Product Code
OOE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2014
Decision Date
03/20/2015
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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