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510(k) K132593

CRYSTALSERT DELIVERY SYSTEM by Bausch & Lomb — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2013
Date Received
August 19, 2013
Clearance Type
Special
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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  • K212039 — CLAREON MONARCH IV IOL Delivery System (August 23, 2021)
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  • K192926 — RxSight Insertion Device (January 17, 2020)
  • K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded (October 4, 2019)
  • K191949 — UNFOLDER Vitan Inserter (September 13, 2019)