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FDA 510(k)

CENTURION VISION SYSTEM

K-Number: K121555 · 2012-12-21

ApplicantAlcon Laboratories, Inc.
Decision Date2012-12-21
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CENTURION VISION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K121555. 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 CENTURION VISION SYSTEM?

CENTURION VISION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K121555.

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

CENTURION VISION SYSTEM received FDA 510(k) clearance on 2012-12-21, under 510(k) number K121555.

Who is the listed applicant for CENTURION VISION SYSTEM?

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

What is the FDA product code for CENTURION VISION SYSTEM?

The FDA product code for CENTURION VISION SYSTEM is HQC.

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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

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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