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FDA 510(k)

MONARCH III IOL DELIVERY SYSTEM

K-Number: K063155 · 2007-03-27

ApplicantAlcon Manufacturing, Ltd.
Decision Date2007-03-27
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MONARCH III IOL DELIVERY SYSTEM 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 2007-03-27 under 510(k) number K063155. The device is classified under product code KYB. 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 IOL DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-27. The listed applicant is Alcon Manufacturing, Ltd.. The 510(k) number is K063155.

When did MONARCH III IOL DELIVERY SYSTEM receive FDA 510(k) clearance?

MONARCH III IOL DELIVERY SYSTEM received FDA 510(k) clearance on 2007-03-27, under 510(k) number K063155.

Who is the listed applicant for MONARCH III IOL DELIVERY SYSTEM?

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?

The FDA product code for MONARCH III IOL DELIVERY SYSTEM is KYB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 HANDPIECEK101774MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)K101285CONSTELLATION VISION SYSTEMK093210AQUALASE CAPSULE WASH TIP

Related Devices (Code: KYB)

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.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.K022723MASTEL 1 FOLDER IMPLANTATION SYSTEMMastel Precision, Inc.

Official Source

View on FDA Database →

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

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