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510(k) K132002

SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR by Rayner Intraocular Lenses , Ltd. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2014
Date Received
July 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Rayner Intraocular Lenses , Ltd.

  • K143307 — RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (December 18, 2014)
  • K141091 — RAYSERT PLUS INJECTOR (May 28, 2014)
  • K091507 — RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (December 4, 2009)

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  • 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)