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FDA 510(k)

AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM

K-Number: K111697 · 2011-09-27

ApplicantAbbott Medical Optics, Inc.
Decision Date2011-09-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Medical Optics, Inc.. It received FDA 510(k) clearance on 2011-09-27 under 510(k) number K111697. 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 AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM?

AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-27. The listed applicant is Abbott Medical Optics, Inc.. The 510(k) number is K111697.

When did AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM receive FDA 510(k) clearance?

AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM received FDA 510(k) clearance on 2011-09-27, under 510(k) number K111697.

Who is the listed applicant for AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM?

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

What is the FDA product code for AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM?

The FDA product code for AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM is HQC.

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Related Devices (Code: HQC)

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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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