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510(k) K003768

MONARCH II IOL DELIVERY SYSTEM by Alcon Research, Ltd. — Product Code MSS

K003768 is an FDA 510(k) premarket notification submitted by Alcon Research, Ltd. for the device "MONARCH II IOL DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 5, 2001. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Alcon Research, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2001
Date Received
December 6, 2000
Clearance Type
Abbreviated
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 Alcon Research, Ltd.

  • K191650 — LEGION System (November 1, 2019)
  • K161794 — CENTURION Vision System (Active SentryTM) (April 14, 2017)
  • K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitre (March 22, 2017)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121031 — WAVELIGHT FS200 PATIENT INTERFACE 1505 (June 21, 2012)
  • K112977 — MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (March 27, 2012)
  • K110951 — 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VAL (October 17, 2011)
  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K102860 — ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (May 10, 2011)
  • K101006 — WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (October 21, 2010)

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