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FDA 510(k)

Z CARTRIDGE IOL DELIVERY SYSTEM

K-Number: K123888 · 2013-04-15

ApplicantAaren Scientific, Inc.
Decision Date2013-04-15
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Z CARTRIDGE IOL DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aaren Scientific, Inc.. It received FDA 510(k) clearance on 2013-04-15 under 510(k) number K123888. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z CARTRIDGE IOL DELIVERY SYSTEM?

Z CARTRIDGE IOL DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-15. The listed applicant is Aaren Scientific, Inc.. The 510(k) number is K123888.

When did Z CARTRIDGE IOL DELIVERY SYSTEM receive FDA 510(k) clearance?

Z CARTRIDGE IOL DELIVERY SYSTEM received FDA 510(k) clearance on 2013-04-15, under 510(k) number K123888.

Who is the listed applicant for Z CARTRIDGE IOL DELIVERY SYSTEM?

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

What is the FDA product code for Z CARTRIDGE IOL DELIVERY SYSTEM?

The FDA product code for Z CARTRIDGE IOL DELIVERY SYSTEM is MSS.

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Related Devices (Code: MSS)

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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