Hoya Surgical Optics Inc

FDA Filings

This page includes the latest FDA filings for Hoya Surgical Optics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Hoya Surgical Optics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3006723646
FEI Number3006723646
NameHOYA SURGICAL OPTICS, INC.
Owner & OperatorHoya Surgical Optics, Inc.
Contact Address15335 Fairfield Ranch Road, Suite 250
Chino Hills CA 91709 US
Official Correspondent
  • Robert Sheehan
  • x-909-6803960-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address15335 Fairfield Ranch Rd Ste 250
Chino Hills, CA 91709 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
HOYA SURGICAL OPTICS, INC.
iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL)2020-06-15
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System, Intraocular Lens - Clarisert2020-03-12
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL Models, iSymm, Clarisert IOL Models2019-12-30
HOYA SURGICAL OPTICS, INC.
iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System2019-12-04
HOYA SURGICAL OPTICS, INC.
iSymm, iSpheric IOL2019-12-04
HOYA SURGICAL OPTICS, INC.
iSert Preloaded System/ iSert Micro Injector2019-11-29
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-IS Injectors and Cartridges (Cartridge Model No. E1)2009-03-24
HOYA SURGICAL OPTICS, INC.
Hoya-IS Injector and Cardtridges (Model No. ISH001, ISH003)2009-03-24
HOYA SURGICAL OPTICS, INC.
HOYA IS INJECTOR SYSTEM2009-03-23
HOYA SURGICAL OPTICS, INC.
iSymm IOL (Model FY-60AD)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSymm IOL (Model FC-60AD)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSpheric IOL (Model YA-60BBR)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSpheric IOL (Model YA-60BB)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System (Model PY-60R)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System (Model PY-60AD)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System (Model PC-60AD)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System (Model No. 231)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System (Model No. 230)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System (Model 251)2009-01-21
HOYA SURGICAL OPTICS, INC.
iSert Preloaded IOL System (Model 250)2009-01-21
HOYA SURGICAL OPTICS, INC.
Clarisert? (Model: CLSRT)2009-01-21
HOYA SURGICAL OPTICS, INC.
HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS2008-09-26

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