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510(k) K060533

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM by Lenstec, Inc. — Product Code MSS

K060533 is an FDA 510(k) premarket notification submitted by Lenstec, Inc. for the device "LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 2006. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Lenstec, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2006
Date Received
February 28, 2006
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 Lenstec, Inc.

  • K161776 — Lenstec LC Injection system (November 29, 2016)
  • K122848 — LENSTEC LC INJECTION SYSTEM (October 18, 2013)
  • K091915 — FLUID ISOLATION DEVICE (October 27, 2009)
  • K063802 — LENSTEC LC INJECTION SYSTEM (May 7, 2007)
  • K050638 — LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES (May 31, 2005)

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