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510(k) K231106

Accuject Refra Injector AR2900 by Medicel AG — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2023
Date Received
April 19, 2023
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 Medicel AG

  • K252540 — ACCUJECT Injector Set 2.1-1P (LP604590) (September 16, 2025)
  • K101134 — VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 (August 9, 2010)
  • K092023 — NAVIJECT SUB2-1P, MODEL: LP604430 (July 28, 2009)
  • K070669 — IOL INJECTOR SET (November 1, 2007)
  • K040837 — MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (June 17, 2004)

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)
  • 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)
  • K182965 — BL-Cart IOL Delivery Cartridge (March 29, 2019)