FDA 510(k)

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K

K-Number: K181579 · 2018-07-26

Decision Date2018-07-26

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K is the device name listed in this FDA 510(k) record. The listed applicant is E&E Optics, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181579. 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 eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K?

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is E&E Optics, Inc.. The 510(k) number is K181579.

When did eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K receive FDA 510(k) clearance?

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181579.

Who is the listed applicant for eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K?

The FDA 510(k) record lists E&E Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K?

The FDA product code for eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K is HQD.

Related Clinical Trials

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.

NCT07494799Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens WearNOT_YET_RECRUITING NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETED NCT05285527MiSight 1 Day Safety Post-Approval StudyACTIVE_NOT_RECRUITING NCT07303920Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear DayRECRUITING NCT05509608Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted SubjectsACTIVE_NOT_RECRUITING NCT0668969624-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP MonitoringCOMPLETED

Related Devices (Code: HQD)

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 Bostonsight K240618Acuity 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.