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FDA 510(k)

INFINITI(R) VISION SYSTEM

K-Number: K120912 · 2012-06-15

ApplicantAlcon Manufacturing, Ltd.
Decision Date2012-06-15
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INFINITI(R) VISION 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 2012-06-15 under 510(k) number K120912. 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(R) VISION SYSTEM?

INFINITI(R) VISION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-15. The listed applicant is Alcon Manufacturing, Ltd.. The 510(k) number is K120912.

When did INFINITI(R) VISION SYSTEM receive FDA 510(k) clearance?

INFINITI(R) VISION SYSTEM received FDA 510(k) clearance on 2012-06-15, under 510(k) number K120912.

Who is the listed applicant for INFINITI(R) VISION 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 INFINITI(R) VISION SYSTEM?

The FDA product code for INFINITI(R) VISION SYSTEM 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.

K112425INFINITI 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 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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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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