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FDA 510(k)

MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)

K-Number: K101774 · 2011-10-13

ApplicantAlcon Manufacturing, Ltd.
Decision Date2011-10-13
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Manufacturing, Ltd.. It received FDA 510(k) clearance on 2011-10-13 under 510(k) number K101774. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)?

MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) is a medical device that received FDA 510(k) clearance on 2011-10-13. The listed applicant is Alcon Manufacturing, Ltd.. The 510(k) number is K101774.

When did MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) receive FDA 510(k) clearance?

MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) received FDA 510(k) clearance on 2011-10-13, under 510(k) number K101774.

Who is the listed applicant for MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)?

The FDA 510(k) record lists Alcon Manufacturing, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)?

The FDA product code for MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) is MSS.

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Other records listing Alcon Manufacturing, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120912INFINITI(R) VISION SYSTEMK112425INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECEK101285CONSTELLATION VISION SYSTEMK093210AQUALASE CAPSULE WASH TIPK063155MONARCH III IOL DELIVERY SYSTEM

Related Devices (Code: MSS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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