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FDA 510(k)

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

K-Number: K172314 · 2017-09-20

ApplicantArt Optical Contact Lens, Inc.
Decision Date2017-09-20
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is a medical device manufactured by Art Optical Contact Lens, Inc.. It received FDA 510(k) clearance on 2017-09-20 under approval number K172314. 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 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is a medical device that received FDA 510(k) clearance on 2017-09-20. It is manufactured by Art Optical Contact Lens, Inc.. The 510(k) number is K172314.

When was Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) approved by the FDA?

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) received FDA 510(k) clearance on 2017-09-20, under approval number K172314.

What company makes Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is manufactured by Art Optical Contact Lens, Inc..

What is the FDA product code for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

The FDA product code for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is HQD.

Other Devices by Art Optical Contact Lens, Inc.

K230824IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

Related Devices (Code: HQD)

K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. K153714SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear CoSynergeyes, Inc. K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. K160938SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc. K161461BostonSight PD Prosthetic DeviceBostonsight K152724EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSESAdvanced Vision Technologies

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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