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510(k) K192005

Bausch + Lomb PreVue Inserter for enVista Preloaded by Bausch & Lomb, Inc. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2019
Date Received
July 29, 2019
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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  • K231106 — Accuject Refra Injector AR2900 (September 19, 2023)
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  • K212039 — CLAREON MONARCH IV IOL Delivery System (August 23, 2021)
  • K200057 — bioli lOL Delivery System (June 4, 2020)
  • K192926 — RxSight Insertion Device (January 17, 2020)
  • K191949 — UNFOLDER Vitan Inserter (September 13, 2019)
  • K182965 — BL-Cart IOL Delivery Cartridge (March 29, 2019)