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510(k) K122829

LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS by Lensar, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2012
Date Received
September 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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  • K123859 — TBD (March 27, 2013)
  • K120214 — TBD (June 8, 2012)

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