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510(k) K141091

RAYSERT PLUS INJECTOR by Rayner Intraocular Lenses , Ltd. — Product Code MSS

K141091 is an FDA 510(k) premarket notification submitted by Rayner Intraocular Lenses , Ltd. for the device "RAYSERT PLUS INJECTOR". The FDA issued a decision of Substantially Equivalent on May 28, 2014. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Rayner Intraocular Lenses , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2014
Date Received
April 28, 2014
Clearance Type
Special
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 Rayner Intraocular Lenses , Ltd.

  • K143307 — RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (December 18, 2014)
  • K132002 — SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL (March 27, 2014)
  • K091507 — RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (December 4, 2009)

Other clearances for product code MSS

  • K261174 — RxSight® Insertion Device (June 10, 2026)
  • K252540 — ACCUJECT Injector Set 2.1-1P (LP604590) (September 16, 2025)
  • 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)

FDA data resources