FDA 510(k)

OxyPure Color Silicone Hydrogel Soft Contact Lenses

K-Number: K171447 · 2017-12-05

Decision Date2017-12-05

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OxyPure Color Silicone Hydrogel Soft Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2017-12-05 under 510(k) number K171447. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OxyPure Color Silicone Hydrogel Soft Contact Lenses?

OxyPure Color Silicone Hydrogel Soft Contact Lenses is a medical device that received FDA 510(k) clearance on 2017-12-05. The listed applicant is Visco Vision, Inc.. The 510(k) number is K171447.

When did OxyPure Color Silicone Hydrogel Soft Contact Lenses receive FDA 510(k) clearance?

OxyPure Color Silicone Hydrogel Soft Contact Lenses received FDA 510(k) clearance on 2017-12-05, under 510(k) number K171447.

Who is the listed applicant for OxyPure Color Silicone Hydrogel Soft Contact Lenses?

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

What is the FDA product code for OxyPure Color Silicone Hydrogel Soft Contact Lenses?

The FDA product code for OxyPure Color Silicone Hydrogel Soft Contact Lenses is LPL.

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.

NCT06995781Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)COMPLETED NCT06778057Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact LensesCOMPLETED NCT04080128Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia ControlCOMPLETED NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETED NCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETED NCT05955638Management of Myopia in University Students Using Dual Focus Soft Contact LensesENROLLING_BY_INVITATION

Other records listing Visco Vision, Inc. as applicant

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Related Devices (Code: LPL)

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.