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FDA 510(k)

VX130 Ophthalmic Diagnostic Device

K-Number: K162067 · 2017-04-24

ApplicantLuneau Sas
Decision Date2017-04-24
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VX130 Ophthalmic Diagnostic Device is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Sas. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K162067. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VX130 Ophthalmic Diagnostic Device?

VX130 Ophthalmic Diagnostic Device is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Luneau Sas. The 510(k) number is K162067.

When did VX130 Ophthalmic Diagnostic Device receive FDA 510(k) clearance?

VX130 Ophthalmic Diagnostic Device received FDA 510(k) clearance on 2017-04-24, under 510(k) number K162067.

Who is the listed applicant for VX130 Ophthalmic Diagnostic Device?

The FDA 510(k) record lists Luneau Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VX130 Ophthalmic Diagnostic Device?

The FDA product code for VX130 Ophthalmic Diagnostic Device is HKX.

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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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