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510(k) K980696

FOAM TIP INJECTOR by Staar Surgical Co. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1998
Date Received
February 23, 1998
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 Staar Surgical Co.

  • K172375 — MicroSTAAR Injector System Cartridges (September 6, 2017)
  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K090161 — EPIPHANY INJECTION SYSTEM (June 9, 2009)
  • K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K073586 — MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K020734 — SURGE-FREE ASPIRATION ADAPTER (May 16, 2002)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (December 21, 1995)
  • K913626 — SOFTRANS INJECTOR (December 18, 1991)

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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)