Home / 510(k) Clearances / K082871

510(k) K082871

XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM by Sis Ltd., Surgical Instrument Systems — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2009
Date Received
September 29, 2008
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 Sis Ltd., Surgical Instrument Systems

  • K051940 — CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA (September 28, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)

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)