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FDA 510(k)

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

K-Number: K183200 · 2019-01-09

ApplicantC&E GP Specialist, Inc.
Decision Date2019-01-09
Product CodeMUW
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is C&E GP Specialist, Inc.. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K183200. The device is classified under product code MUW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is C&E GP Specialist, Inc.. The 510(k) number is K183200.

When did iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses receive FDA 510(k) clearance?

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses received FDA 510(k) clearance on 2019-01-09, under 510(k) number K183200.

Who is the listed applicant for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

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

What is the FDA product code for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

The FDA product code for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is MUW.

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_RECRUITINGNCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETEDNCT06749496Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of WearCOMPLETEDNCT07303920Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear DayRECRUITINGNCT06751225Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With AstigmatismCOMPLETEDNCT06878118The A.R.R.E.S.T.® Contact Lens StudyACTIVE_NOT_RECRUITING

Related Devices (Code: MUW)

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.

K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd.

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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