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FDA 510(k)

METRO FOCAL ASPHERIC (POLYMACON)

K-Number: K961606 · 1996-11-20

ApplicantMetro Optics of Austin, Inc.
Decision Date1996-11-20
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

METRO FOCAL ASPHERIC (POLYMACON) is the device name listed in this FDA 510(k) record. The listed applicant is Metro Optics of Austin, Inc.. It received FDA 510(k) clearance on 1996-11-20 under 510(k) number K961606. 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 METRO FOCAL ASPHERIC (POLYMACON)?

METRO FOCAL ASPHERIC (POLYMACON) is a medical device that received FDA 510(k) clearance on 1996-11-20. The listed applicant is Metro Optics of Austin, Inc.. The 510(k) number is K961606.

When did METRO FOCAL ASPHERIC (POLYMACON) receive FDA 510(k) clearance?

METRO FOCAL ASPHERIC (POLYMACON) received FDA 510(k) clearance on 1996-11-20, under 510(k) number K961606.

Who is the listed applicant for METRO FOCAL ASPHERIC (POLYMACON)?

The FDA 510(k) record lists Metro Optics of Austin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METRO FOCAL ASPHERIC (POLYMACON)?

The FDA product code for METRO FOCAL ASPHERIC (POLYMACON) is LPL.

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Other records listing Metro Optics of Austin, Inc. 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.

K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)K100244METRO SOFTK080512REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINTK031532SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEARK001620METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LENK990264COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS

View all 8 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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