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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 the device name listed in this FDA 510(k) record. The listed applicant is Art Optical Contact Lens, Inc.. It received FDA 510(k) clearance on 2017-09-20 under 510(k) 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. The listed applicant is Art Optical Contact Lens, Inc.. The 510(k) number is K172314.

When did Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) receive FDA 510(k) clearance?

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

Who is the listed applicant for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

The FDA 510(k) record lists Art Optical Contact Lens, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Art Optical Contact Lens, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: HQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

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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