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510(k) K113852

BAUSCH & LOMB IOL INJECTOR by Bausch & Lomb, Inc. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2012
Date Received
December 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

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  • K192926 — RxSight Insertion Device (January 17, 2020)
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  • K191949 — UNFOLDER Vitan Inserter (September 13, 2019)