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510(k) K252540

ACCUJECT Injector Set 2.1-1P (LP604590) by Medicel AG — Product Code MSS

K252540 is an FDA 510(k) premarket notification submitted by Medicel AG for the device "ACCUJECT Injector Set 2.1-1P (LP604590)". The FDA issued a decision of Substantially Equivalent on September 16, 2025. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Medicel AG has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2025
Date Received
August 12, 2025
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

  • K231106 — Accuject Refra Injector AR2900 (September 19, 2023)
  • 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

  • K261174 — RxSight® Insertion Device (June 10, 2026)
  • 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)

FDA data resources