HOYA SURGICAL OPTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3006723646	3006723646	HOYA SURGICAL OPTICS, INC.	1	N	2026-01-01	110 Progress Ave., Suite 175 Irvine CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
90656	1487569393	P080004	HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS	HQL	2008-09-26
90656	1631499490	K081346	HOYA IS INJECTOR SYSTEM	MSS	2009-03-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MSS	1	2009-03-23
HQL	1	2008-09-26

PMA#

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 ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
2008-09-26
HOYA SURGICAL OPTICS, INC.

PMN#

HOYA IS INJECTOR SYSTEM
2009-03-23
HOYA SURGICAL OPTICS, INC.