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510(k) K181401

RxSight Insertion Device by Rxsight, Inc. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2018
Date Received
May 29, 2018
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 Rxsight, Inc.

  • K231838 — RxSight® Insertion Device (63002) (August 15, 2023)
  • K231466 — RxSight Insertion Device (June 12, 2023)
  • K201909 — RxSight Contact Lens (September 10, 2020)
  • K192926 — RxSight Insertion Device (January 17, 2020)

Other clearances for product code MSS

  • 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)
  • K191949 — UNFOLDER Vitan Inserter (September 13, 2019)