FDA 510(k)

Toricolors (hioxifilcon D) Soft Contact Lenses

K-Number: K161931 · 2016-10-12

Decision Date2016-10-12

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Toricolors (hioxifilcon D) Soft Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Polydev , Ltd.. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K161931. 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 Toricolors (hioxifilcon D) Soft Contact Lenses?

Toricolors (hioxifilcon D) Soft Contact Lenses is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Polydev , Ltd.. The 510(k) number is K161931.

When did Toricolors (hioxifilcon D) Soft Contact Lenses receive FDA 510(k) clearance?

Toricolors (hioxifilcon D) Soft Contact Lenses received FDA 510(k) clearance on 2016-10-12, under 510(k) number K161931.

Who is the listed applicant for Toricolors (hioxifilcon D) Soft Contact Lenses?

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

What is the FDA product code for Toricolors (hioxifilcon D) Soft Contact Lenses?

The FDA product code for Toricolors (hioxifilcon D) 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.

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 NCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETED NCT06749496Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of WearCOMPLETED

Other records listing Polydev , Ltd. as applicant

K171157PolyDev Soft Contact Lenses K160977PolyDev Soft Contact Lenses

Related Devices (Code: LPL)

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.