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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 10 Results
ProductCode: LPL Applicant: ALDEN OPTICAL LABS., INC. Decision Date To: 06/04/2023
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io2 spher(mangofilcon a) soft (hydrophilic) contact lens for daily wear,io2 toric (mangofilcon a) soft (hydrophilic) ALDEN OPTICAL LABS., INC. K133079 12/17/2013
novakone spherical and toric lenses ALDEN OPTICAL LABS., INC. K102557 04/26/2011
alden hp 54 sphee 7 hip 54 toric contact lenses, alden hp 54 multifocal &hp 54 toric multifocal contact lenses ALDEN OPTICAL LABS., INC. K091327 06/25/2010
alden classic (polymacon) multifocal (spherical and toric), alden classic 55 (methafilcon a) multifocal (spherical ALDEN OPTICAL LABS., INC. K052703 11/10/2005
alden hp (hioxifilcon b) sphere & toric soft contact lenses ALDEN OPTICAL LABS., INC. K042242 09/15/2004
oxylens tinted, prosthetic (hioxifilcon b) tinted, soft daily wear contact lens (sighted an non-sighted eyes) ALDEN OPTICAL LABS., INC. K983278 11/25/1998
alden classic prosthetic (polymacon) tinted, soft daily wear contact lens (sighted and non-sighted eyes) ALDEN OPTICAL LABS., INC. K983053 10/21/1998
oxylens (hioxifilcon b) soft (spherical & toric) daily wear contact lenss (clear & blue visibility tinted, lathe-cut fr) ALDEN OPTICAL LABS., INC. K981252 06/23/1998
alden classic tinted (polymacon) soft (spherical & toric) daily wear contact lens, tinted (transparent/enhancing) ALDEN OPTICAL LABS., INC. K980554 04/07/1998
al-47 (polymacon) soft (spherical & toric) daily wear contact lens (clear & tinted, lathe-cut from lens blank) ALDEN OPTICAL LABS., INC. K973967 12/08/1997
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