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FDA 510(k)

EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES

K-Number: K152724 · 2016-04-27

ApplicantAdvanced Vision Technologies
Decision Date2016-04-27
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES is a medical device manufactured by Advanced Vision Technologies. It received FDA 510(k) clearance on 2016-04-27 under approval number K152724. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES?

EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES is a medical device that received FDA 510(k) clearance on 2016-04-27. It is manufactured by Advanced Vision Technologies. The 510(k) number is K152724.

When was EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES approved by the FDA?

EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES received FDA 510(k) clearance on 2016-04-27, under approval number K152724.

What company makes EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES?

EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES is manufactured by Advanced Vision Technologies.

What is the FDA product code for EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES?

The FDA product code for EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES is HQD.

Related Clinical Trials

NCT07288658 Comparing the Fit and Performance of Scleral Lenses With Oval and Circular Limbal Zones COMPLETED NCT07559188 Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus NOT_YET_RECRUITING NCT05973409 Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye COMPLETED

Related Devices (Code: HQD)

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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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