Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Advanced Vision Technologies. It received FDA 510(k) clearance on 2016-04-27 under 510(k) 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. The listed applicant is Advanced Vision Technologies. The 510(k) number is K152724.

When did EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES receive FDA 510(k) clearance?

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

Who is the listed applicant for EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES?

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

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 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑