STAAR SURGICAL COMPANY

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2023826	2023826	STAAR SURGICAL COMPANY	1	Y	2026-01-01	1911 WALKER AVE. MONROVIA CA US 91016
3014173684	3014173684	STAAR Surgical Company	1	Y	2026-01-01	15102 Red Hill Avenue Tustin CA US 92780

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
214228	1596743265	P990013	COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	2000-04-02
4916	1596743265	P990013	COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	2000-04-02
4916	1953673311	P900048	ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM		1991-09-17
4916	2001508166	P880091	ELASTIC UVA PC IOL.	HQL	1991-09-16
214228	2001508166	P880091	ELASTIC UVA PC IOL.	HQL	1991-09-16
4916	1829508920	P030016	VISIAN ICL (IMPLANTABLE COLLAMER LENS)	MTA	2005-12-22
214228	1829508920	P030016	VISIAN ICL (IMPLANTABLE COLLAMER LENS)	MTA	2005-12-22
4916	1345488458	K980696	FOAM TIP INJECTOR	MSS	1998-09-11
214228	1345488458	K980696	FOAM TIP INJECTOR	MSS	1998-09-11
4916	1426161626	K954600	MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)	KYB	1995-12-21
214228	1426161626	K954600	MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)	KYB	1995-12-21
4916	1311006380	K940593	DISPOSABLE MICROSTAAR INJECTOR	KYB	1994-09-19
214228	1311006380	K940593	DISPOSABLE MICROSTAAR INJECTOR	KYB	1994-09-19
4916	1518917393	K172375	MicroSTAAR Injector System Cartridges	MSS	2017-09-06
214228	1518917393	K172375	MicroSTAAR Injector System Cartridges	MSS	2017-09-06
4916	1181169391	K152357	MicroSTAAR Injector System Cartridges	KYB	2015-10-30
214228	1181169391	K152357	MicroSTAAR Injector System Cartridges	KYB	2015-10-30
4916	1772562441	K101782	MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE	MSS	2010-12-22
214228	1772562441	K101782	MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE	MSS	2010-12-22
4916	1887572367	K090161	EPIPHANY INJECTION SYSTEM	MSS	2009-06-09
214228	1887572367	K090161	EPIPHANY INJECTION SYSTEM	MSS	2009-06-09
4916	1291626502	K073586	MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM	MSS	2008-03-13
214228	1291626502	K073586	MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM	MSS	2008-03-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MSS	10	2017-09-06
KYB	6	2015-10-30
HQL	3	1991-09-17
MTA	2	2005-12-22
HQL	2	2000-04-02

PMA#

Visian Implantable Collamer Lens (ICL)
2021-07-19
STAAR Surgical Company
Visian Implantable Collamer Lens
2020-03-31
STAAR Surgical Company
Visian Implantable Collamer Lens
2019-07-26
STAAR Surgical Company
Visian Toric ICL (Implantable Collamer Lens)
2019-07-19
STAAR Surgical Company
Visian ICL (Implantable Collamer Lens)
2019-04-15
STAAR Surgical Company
Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
2019-03-07
STAAR Surgical Company
Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
2018-09-13
STAAR Surgical Company
Visian Implantable Collamer Lens for Myopia
2017-08-04
STAAR Surgical Company
Visian Implantable Collamer Lens for Myopia
2017-07-20
STAAR Surgical Company
Visian Implantable Collamer Lens for Myopia
2017-06-16
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL)
2017-03-08
STAAR Surgical Company
VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA
2017-01-25
STAAR Surgical Company
VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)
2015-12-10
STAAR Surgical Company
VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)
2015-11-17
STAAR Surgical Company
VISIAN IMPLANTABLE COLLAMER LENSES
2014-12-22
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA
2014-02-10
STAAR Surgical Company
COLLAMER VISIAN IMPLANTABLE COLLAMER LENS MICL
2013-08-22
STAAR Surgical Company
IMPLANTABLE COLLAMER LENS (VISIAN ICL)
2012-06-08
STAAR Surgical Company
VISIAN ICL
2011-05-05
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA
2011-05-04
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)
2011-04-08
STAAR Surgical Company
VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA
2010-09-15
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENS
2010-08-26
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENS
2010-08-26
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENS
2010-07-29
STAAR Surgical Company
STAAR VISION IMPLANTABLE COLLAMER LENS
2009-04-02
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA
2009-03-11
STAAR Surgical Company
STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER
2009-01-14
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA
2008-09-10
STAAR Surgical Company
STAAR SURGICAL COLLAMER UV ¿ ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
2008-09-04
STAAR Surgical Company
STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER
2008-07-11
STAAR Surgical Company
STAAR VISIAN IMPLANTABLE COLLAMER LENS
2008-05-23
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENSES
2008-04-24
STAAR Surgical Company
STAAR SURGICAL IMPLANTABLE COLLAMER LENSES
2008-04-16
STAAR Surgical Company
VISIAN IMPLANTABLE COLLAMER LENS
2008-03-26
STAAR Surgical Company
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
2005-12-22
STAAR Surgical Company

PMN#

MicroSTAAR Injector System Cartridges
2017-09-06
STAAR Surgical Company
MicroSTAAR Injector System Cartridges
2015-10-30
STAAR Surgical Company

GUDID#

EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -3.5; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -4.0; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -4.5; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -5.0; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -5.5; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -7.5; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -8.0; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -11.0; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -11.5; Overall Diameter (Length): 12.1
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -5.5; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -6.0; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -6.5; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -9.0; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -9.5; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -10.0; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -11.0; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -11.5; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -12.0; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -12.5; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -13.0; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -13.5; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -14.0; Overall Diameter (Length): 12.6
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -3.5; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -4.0; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -4.5; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -5.5; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -8.0; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -8.5; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -9.0; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -9.5; Overall Diameter (Length): 13.2
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -4.0; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -4.5; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -5.0; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -6.5; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -7.0; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -8.5; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -9.5; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -11.5; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -12.0; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30
EVO/EVO+VISIAN Implantable Collamer Lens - VICM5 - Diopter: -12.5; Overall Diameter (Length): 13.7
STAAR SURGICAL COMPANY
2023-11-30

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