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510(k) K081545

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 by Advanced Medical Optics, Inc. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2008
Date Received
June 2, 2008
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

Other clearances by Advanced Medical Optics, Inc.

  • K081681 — VITRECTOMY CUTTER AND ACCESSORIES (October 8, 2008)
  • K060366 — THE AMO OPHTHALMIC SURGICAL SYSTEM (April 7, 2006)
  • K042562 — LENS PLUS REWETTING DROPS (July 29, 2005)
  • K050648 — SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (April 5, 2005)
  • K040839 — COMPLETE BLINK-N-CLEAN LENS DROPS (October 19, 2004)
  • K032030 — BLINK CL LUBRICANT EYE DROPS (September 25, 2003)
  • K030092 — COMPLETE BRAND MULTI-PURPOSE SOLUTION (April 4, 2003)

Other clearances for product code MSS

  • K252540 — ACCUJECT Injector Set 2.1-1P (LP604590) (September 16, 2025)
  • K242389 — EyeGility™ Inserter for Preloaded enVista IOLs (October 10, 2024)
  • K231106 — Accuject Refra Injector AR2900 (September 19, 2023)
  • K231838 — RxSight® Insertion Device (63002) (August 15, 2023)
  • K231466 — RxSight Insertion Device (June 12, 2023)
  • 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)
  • K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded (October 4, 2019)
  • K191949 — UNFOLDER Vitan Inserter (September 13, 2019)