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FDA 510(k)

CONSTELLATION VISION SYSTEM

K-Number: K101285 · 2010-11-12

ApplicantAlcon Manufacturing, Ltd.
Decision Date2010-11-12
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CONSTELLATION 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 2010-11-12 under 510(k) number K101285. 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 CONSTELLATION VISION SYSTEM?

CONSTELLATION VISION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-12. The listed applicant is Alcon Manufacturing, Ltd.. The 510(k) number is K101285.

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

CONSTELLATION VISION SYSTEM received FDA 510(k) clearance on 2010-11-12, under 510(k) number K101285.

Who is the listed applicant for CONSTELLATION 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 CONSTELLATION VISION SYSTEM?

The FDA product code for CONSTELLATION 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.

K120912INFINITI(R) VISION SYSTEMK112425INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECEK101774MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)K093210AQUALASE 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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