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510(k) K143307

RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector by Rayner Intraocular Lenses , Ltd. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2014
Date Received
November 18, 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.

  • K141091 — RAYSERT PLUS INJECTOR (May 28, 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)

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  • K212039 — CLAREON MONARCH IV IOL Delivery System (August 23, 2021)
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  • K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded (October 4, 2019)
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