HOYA SURGICAL OPTICS, INC

FDA Filings

This page includes the latest FDA filings for HOYA SURGICAL OPTICS, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
HOYA SURGICAL OPTICS, INC.
iSert Intraocular Lenses (IOLs)2019-08-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System2018-10-11
HOYA SURGICAL OPTICS, INC.
Preset Tips2018-08-06
HOYA SURGICAL OPTICS, INC.
Hoya iSert, Clarisert Intraocular Lens2018-04-25
HOYA SURGICAL OPTICS, INC.
Hoya iSert and Clarisert Intraocular Lens2018-02-01
HOYA SURGICAL OPTICS, INC.
Clarisert Preloaded IOL System2017-12-19
HOYA SURGICAL OPTICS, INC.
Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems2017-10-13
HOYA SURGICAL OPTICS, INC.
CLARISERT PRELOADED IOL SYSTEM2017-03-31
HOYA SURGICAL OPTICS, INC.
ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)2014-06-16
HOYA SURGICAL OPTICS, INC.
I SERT MODEL 251 PRELOADED POSTERIOR CHAMBER INTRACULAR LENS; I SERT MODEL 250 PRELOADED POSTER CHANBER INTRAOCULAR LEN2013-09-26
HOYA SURGICAL OPTICS, INC.
ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL2013-07-10
HOYA SURGICAL OPTICS, INC.
ISERT GEMETRIC2013-03-13
HOYA SURGICAL OPTICS, INC.
ISERT MODEL PC-60AD PACKAGING IMPROVEMENT2012-07-17
HOYA SURGICAL OPTICS, INC.
EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING2012-06-13
HOYA SURGICAL OPTICS, INC.
CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES2012-04-04
HOYA SURGICAL OPTICS, INC.
BIOLOGICAL INDICATOR (BI)2012-01-20
HOYA SURGICAL OPTICS, INC.
LIMULUS AMEBOCYTE LYSATE BACTERIA TEST2011-10-26
HOYA SURGICAL OPTICS, INC.
ISERT PY-60AD2011-06-15
HOYA SURGICAL OPTICS, INC.
HOYA ISPHERIC INTRAOCULAR LENS2011-04-07
HOYA SURGICAL OPTICS, INC.
INTRAOCULAR LENS2010-07-30
HOYA SURGICAL OPTICS, INC.
ISPHERIC MODEL YA-60BB INTRAOCULAR LENS2009-08-07
HOYA SURGICAL OPTICS, INC.
INTRAOCULAR LENS2009-07-23
HOYA SURGICAL OPTICS, INC.
HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS2008-09-26

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate

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