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FDA 510(k)

Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses

K-Number: K180985 · 2018-06-08

ApplicantSupervision Optimax Sdn Bhd
Decision Date2018-06-08
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Supervision Optimax Sdn Bhd. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K180985. 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 Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses?

Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Supervision Optimax Sdn Bhd. The 510(k) number is K180985.

When did Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses receive FDA 510(k) clearance?

Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses received FDA 510(k) clearance on 2018-06-08, under 510(k) number K180985.

Who is the listed applicant for Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses?

The FDA 510(k) record lists Supervision Optimax Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses?

The FDA product code for Aveo (omafilcon A) Soft (Hydrophilic) 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 ControlCOMPLETEDNCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETEDNCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETEDNCT05955638Management of Myopia in University Students Using Dual Focus Soft Contact LensesENROLLING_BY_INVITATIONNCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETEDNCT06749496Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of WearCOMPLETED

Other records listing Supervision Optimax Sdn Bhd 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.

K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

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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