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FDA 510(k)

AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS

K-Number: K002408 · 2000-10-17

ApplicantUnilens Corp., USA
Decision Date2000-10-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Unilens Corp., USA. It received FDA 510(k) clearance on 2000-10-17 under 510(k) number K002408. 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 AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS?

AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS is a medical device that received FDA 510(k) clearance on 2000-10-17. The listed applicant is Unilens Corp., USA. The 510(k) number is K002408.

When did AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS receive FDA 510(k) clearance?

AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS received FDA 510(k) clearance on 2000-10-17, under 510(k) number K002408.

Who is the listed applicant for AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS?

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

What is the FDA product code for AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS?

The FDA product code for AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS is LPL.

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Other records listing Unilens Corp., USA 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.

K121652CVUE ADVANCED HYDRA VUEK110452SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,K100456CVUE ADVANCED DEFINITIVEK082393CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENSK050743AQUAFLEX 2 (TEFILCON) CONTACT LENSK041608C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS

View all 13 devices →

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.

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.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.

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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