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510(k) K001157

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

K001157 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 June 27, 2000. The device falls under product code KYB (Lens, Guide, Intraocular), 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
June 27, 2000
Date Received
April 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
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 KYB

  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K081382 — DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (October 23, 2008)
  • K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (June 20, 2008)
  • K070669 — IOL INJECTOR SET (November 1, 2007)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)
  • K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (March 7, 2007)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K022723 — MASTEL 1 FOLDER IMPLANTATION SYSTEM (December 26, 2002)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K981571 — MONARCH IOL DELIVERY SYSTEM (July 9, 1998)

FDA data resources