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510(k) K070669

IOL INJECTOR SET by Medicel AG — Product Code KYB

K070669 is an FDA 510(k) premarket notification submitted by Medicel AG for the device "IOL INJECTOR SET". The FDA issued a decision of Substantially Equivalent on November 1, 2007. The device falls under product code KYB (Lens, Guide, Intraocular), 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
November 1, 2007
Date Received
March 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
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)
  • 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)
  • K040837 — MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (June 17, 2004)

Other clearances for product code KYB

  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K081382 — DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (October 23, 2008)
  • K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (June 20, 2008)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)
  • K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (March 7, 2007)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K022723 — MASTEL 1 FOLDER IMPLANTATION SYSTEM (December 26, 2002)
  • K001157 — MONARCH II IOL DELIVERY SYSTEM (June 27, 2000)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K981571 — MONARCH IOL DELIVERY SYSTEM (July 9, 1998)

FDA data resources