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:
| Registration Number | 3006723646 |
| FEI Number | 3006723646 |
| Name | HOYA SURGICAL OPTICS, INC. |
| Owner & Operator | Hoya Surgical Optics, Inc. |
| Contact Address | 15335 Fairfield Ranch Road, Suite 250 Chino Hills CA 91709 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 15335 Fairfield Ranch Rd Ste 250 Chino Hills, CA 91709 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| HOYA SURGICAL OPTICS, INC. | iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System | 2021-12-28 |
| HOYA SURGICAL OPTICS, INC. | PreVue Pre-loaded System, IPURE Pre-loaded System | 2021-06-10 |
| HOYA SURGICAL OPTICS, INC. | iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System | 2021-05-07 |
| HOYA SURGICAL OPTICS, INC. | iSert Preloaded IOL System | 2021-01-13 |
| HOYA SURGICAL OPTICS, INC. | iSert Preloaded IOL System | 2021-01-08 |
| HOYA SURGICAL OPTICS, INC. | iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses | 2020-10-13 |
| 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 - Clarisert | 2020-03-12 |
| HOYA SURGICAL OPTICS, INC. | iSert Preloaded IOL Models, iSymm, Clarisert IOL Models | 2019-12-30 |
| HOYA SURGICAL OPTICS, INC. | iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System | 2019-12-04 |
| HOYA SURGICAL OPTICS, INC. | iSymm, iSpheric IOL | 2019-12-04 |
| HOYA SURGICAL OPTICS, INC. | iSert Preloaded System/ iSert Micro Injector | 2019-11-29 |
| 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 System | 2018-10-11 |
| HOYA SURGICAL OPTICS, INC. | Preset Tips | 2018-08-06 |
| HOYA SURGICAL OPTICS, INC. | Hoya iSert, Clarisert Intraocular Lens | 2018-04-25 |
| HOYA SURGICAL OPTICS, INC. | Hoya iSert and Clarisert Intraocular Lens | 2018-02-01 |
| HOYA SURGICAL OPTICS, INC. | Clarisert Preloaded IOL System | 2017-12-19 |
| HOYA SURGICAL OPTICS, INC. | Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems | 2017-10-13 |
| HOYA SURGICAL OPTICS, INC. | CLARISERT PRELOADED IOL SYSTEM | 2017-03-31 |
| 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 LEN | 2013-09-26 |
| HOYA SURGICAL OPTICS, INC. | ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL | 2013-07-10 |
| HOYA SURGICAL OPTICS, INC. | ISERT GEMETRIC | 2013-03-13 |
| HOYA SURGICAL OPTICS, INC. | ISERT MODEL PC-60AD PACKAGING IMPROVEMENT | 2012-07-17 |
| HOYA SURGICAL OPTICS, INC. | EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING | 2012-06-13 |
| HOYA SURGICAL OPTICS, INC. | CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES | 2012-04-04 |
| HOYA SURGICAL OPTICS, INC. | BIOLOGICAL INDICATOR (BI) | 2012-01-20 |
| HOYA SURGICAL OPTICS, INC. | LIMULUS AMEBOCYTE LYSATE BACTERIA TEST | 2011-10-26 |
| HOYA SURGICAL OPTICS, INC. | ISERT PY-60AD | 2011-06-15 |
| HOYA SURGICAL OPTICS, INC. | HOYA ISPHERIC INTRAOCULAR LENS | 2011-04-07 |
| HOYA SURGICAL OPTICS, INC. | INTRAOCULAR LENS | 2010-07-30 |
| HOYA SURGICAL OPTICS, INC. | ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | 2009-08-07 |
| HOYA SURGICAL OPTICS, INC. | INTRAOCULAR LENS | 2009-07-23 |
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 SYSTEM | 2009-03-23 |
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 LENS | 2008-09-26 |