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Hoya Surgical Optics, Inc.

46 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure™ Preloaded IOL System / Model B1PC (Clear (P080004/S047)Hoya Surgical Optics, Inc.2023-10-25
iSert Preloaded IOL System, IPure™ Preloaded IOL System (P080004/S045)Hoya Surgical Optics, Inc.2023-06-22
iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure™ Preloaded IOL System/ Model B1PC (Clear (P080004/S046)Hoya Surgical Optics, Inc.2023-05-04
PreVue Pre-Loaded System (P080004/S042)Hoya Surgical Optics, Inc.2022-02-28
iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System (P080004/S043)Hoya Surgical Optics, Inc.2021-12-28
PreVue Pre-loaded System, IPURE Pre-loaded System (P080004/S041)Hoya Surgical Optics, Inc.2021-06-10
iSert Preloaded System (P080004/S031)Hoya Surgical Optics, Inc.2021-05-21
iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System (P080004/S040)Hoya Surgical Optics, Inc.2021-05-07
ezSert Preloaded Delivery System (P080004/S036)Hoya Surgical Optics, Inc.2021-03-01
AF-1 Family of Intraocular Lens (IOL) (P080004/S033)Hoya Surgical Optics, Inc.2021-02-26
iSert Preloaded IOL System (P080004/S039)Hoya Surgical Optics, Inc.2021-01-13
iSert Preloaded IOL System (P080004/S038)Hoya Surgical Optics, Inc.2021-01-08
PreVue Preloaded IOL System (P080004/S035)Hoya Surgical Optics, Inc.2020-11-03
iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses (P080004/S037)Hoya Surgical Optics, Inc.2020-10-13
iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL) (P080004/S034)Hoya Surgical Optics, Inc.2020-06-15
IPure Preloaded IOL System (P080004/S028)Hoya Surgical Optics, Inc.2020-04-23
IPure Preloaded IOL System (P080004/S030)Hoya Surgical Optics, Inc.2020-04-17
iSert Preloaded IOL System, Intraocular Lens - Clarisert (P080004/S032)Hoya Surgical Optics, Inc.2020-03-12
iSert Preloaded IOL Models, iSymm, Clarisert IOL Models (P080004/S029)Hoya Surgical Optics, Inc.2019-12-30
iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System (P080004/S027)Hoya Surgical Optics, Inc.2019-12-04
iSymm, iSpheric IOL (P080004/S026)Hoya Surgical Optics, Inc.2019-12-04
iSert Preloaded System/ iSert Micro Injector (P080004/S025)Hoya Surgical Optics, Inc.2019-11-29
HOYA iSert 250/251 and Clarisert Pre-Loaded IOL Injector System (P080004/S023)Hoya Surgical Optics, Inc.2019-10-25
iSert Intraocular Lenses (IOLs) (P080004/S024)Hoya Surgical Optics, Inc.2019-08-21
iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System (P080004/S019)Hoya Surgical Optics, Inc.2018-10-11
Preset Tips (P080004/S017)Hoya Surgical Optics, Inc.2018-08-06
Hoya iSert, Clarisert Intraocular Lens (P080004/S022)Hoya Surgical Optics, Inc.2018-04-25
Hoya iSert and Clarisert Intraocular Lens (P080004/S021)Hoya Surgical Optics, Inc.2018-02-01
Clarisert Preloaded IOL System (P080004/S020)Hoya Surgical Optics, Inc.2017-12-19
Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems (P080004/S018)Hoya Surgical Optics, Inc.2017-10-13
CLARISERT PRELOADED IOL SYSTEM (P080004/S016)Hoya Surgical Optics, Inc.2017-03-31
ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL) (P080004/S015)Hoya Surgical Optics, Inc.2014-06-16
I SERT MODEL 251 PRELOADED POSTERIOR CHAMBER INTRACULAR LENS; I SERT MODEL 250 PRELOADED POSTER CHANBER INTRAOCULAR LEN (P080004/S014)Hoya Surgical Optics, Inc.2013-09-26
ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL (P080004/S011)Hoya Surgical Optics, Inc.2013-07-10
ISERT GEMETRIC (P080004/S013)Hoya Surgical Optics, Inc.2013-03-13
ISERT MODEL PC-60AD PACKAGING IMPROVEMENT (P080004/S012)Hoya Surgical Optics, Inc.2012-07-17
EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING (P080004/S008)Hoya Surgical Optics, Inc.2012-06-13
CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES (P080004/S004)Hoya Surgical Optics, Inc.2012-04-04
BIOLOGICAL INDICATOR (BI) (P080004/S010)Hoya Surgical Optics, Inc.2012-01-20
LIMULUS AMEBOCYTE LYSATE BACTERIA TEST (P080004/S009)Hoya Surgical Optics, Inc.2011-10-26
ISERT PY-60AD (P080004/S007)Hoya Surgical Optics, Inc.2011-06-15
HOYA ISPHERIC INTRAOCULAR LENS (P080004/S006)Hoya Surgical Optics, Inc.2011-04-07
INTRAOCULAR LENS (P080004/S005)Hoya Surgical Optics, Inc.2010-07-30
ISPHERIC MODEL YA-60BB INTRAOCULAR LENS (P080004/S001)Hoya Surgical Optics, Inc.2009-08-07
INTRAOCULAR LENS (P080004/S002)Hoya Surgical Optics, Inc.2009-07-23
HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS (P080004)Hoya Surgical Optics, Inc.2008-09-26

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Every clearance here is in the API, with alerts when new ones post.