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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 a medical device manufactured by Luneau Sas. It received FDA 510(k) clearance on 2017-04-24 under approval 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. It is manufactured by Luneau Sas. The 510(k) number is K162067.

When was VX130 Ophthalmic Diagnostic Device approved by the FDA?

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

What company makes VX130 Ophthalmic Diagnostic Device?

VX130 Ophthalmic Diagnostic Device is manufactured by Luneau Sas.

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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Related PubMed Literature

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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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