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FDA 510(k)

INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE

K-Number: K112425 · 2011-11-21

ApplicantAlcon Manufacturing, Ltd.
Decision Date2011-11-21
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE 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 2011-11-21 under 510(k) number K112425. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE?

INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE is a medical device that received FDA 510(k) clearance on 2011-11-21. The listed applicant is Alcon Manufacturing, Ltd.. The 510(k) number is K112425.

When did INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE receive FDA 510(k) clearance?

INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE received FDA 510(k) clearance on 2011-11-21, under 510(k) number K112425.

Who is the listed applicant for INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE?

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 INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE?

The FDA product code for INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE is HQC.

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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 SYSTEMK101774MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)K101285CONSTELLATION VISION SYSTEMK093210AQUALASE CAPSULE WASH TIPK063155MONARCH III IOL DELIVERY SYSTEM

Related Devices (Code: HQC)

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.

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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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