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FDA 510(k)

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)

K-Number: K973967 · 1997-12-08

ApplicantAlden Optical Labs., Inc.
Decision Date1997-12-08
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) is the device name listed in this FDA 510(k) record. The listed applicant is Alden Optical Labs., Inc.. It received FDA 510(k) clearance on 1997-12-08 under 510(k) number K973967. 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 AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)?

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) is a medical device that received FDA 510(k) clearance on 1997-12-08. The listed applicant is Alden Optical Labs., Inc.. The 510(k) number is K973967.

When did AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) receive FDA 510(k) clearance?

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) received FDA 510(k) clearance on 1997-12-08, under 510(k) number K973967.

Who is the listed applicant for AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)?

The FDA 510(k) record lists Alden Optical Labs., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)?

The FDA product code for AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) is LPL.

Related Clinical Trials

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Other records listing Alden Optical Labs., 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.

K133079IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)K102557NOVAKONE SPHERICAL AND TORIC LENSESK091327ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSESK052703ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICALK042242ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSESK983278OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)

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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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