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510(k) K143434

One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series by Abbott Medical Optics, Inc. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2015
Date Received
December 1, 2014
Clearance Type
Abbreviated
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)