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FDA 510(k)

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

K-Number: K191929 · 2019-09-17

ApplicantUnicon Optical Co., Ltd.
Decision Date2019-09-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Unicon Optical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K191929. 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 UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Unicon Optical Co., Ltd.. The 510(k) number is K191929.

When did UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2019-09-17, under 510(k) number K191929.

Who is the listed applicant for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

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

What is the FDA product code for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

The FDA product code for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens 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 ControlCOMPLETEDNCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETEDNCT05285527MiSight 1 Day Safety Post-Approval StudyACTIVE_NOT_RECRUITINGNCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETEDNCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETEDNCT06751225Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With AstigmatismCOMPLETED

Other records listing Unicon Optical Co., Ltd. as applicant

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.

K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensK182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac

Related Devices (Code: LPL)

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.

K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision Corporation

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.

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