LENSTEC, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1063199	3001659659	LENSTEC, INC.	1	Y	2026-01-01	1765 Commerce Ave N Saint Petersburg FL US 33716

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
77568	1151146136	P200020	SBL-3 Multifocal Intraocular Lens	MFK	2022-07-22
77568	1032075747	P090022	LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	2010-04-12
77568	1807188643	K161776	Lenstec LC Injection system	MSS	2016-11-29
77568	1907057736	K063802	LENSTEC LC INJECTION SYSTEM	MSS	2007-05-07
77568	1548634745	K060533	LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM	MSS	2006-04-14
77568	1086859186	K050638	LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES	MSS	2005-05-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MSS	4	2016-11-29
MFK	1	2022-07-22
HQL	1	2010-04-12

PMA#

Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM
2021-09-28
LENSTEC, INC.
Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
2021-01-07
LENSTEC, INC.
Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
2020-10-23
LENSTEC, INC.
Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
2020-10-15
LENSTEC, INC.
Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs
2018-09-06
LENSTEC, INC.
Lenstec Softec HD aspheric posterior chamber intraocular lens
2017-06-05
LENSTEC, INC.
Lenstec Softec HD Posterior Chamber Intraocular Lens
2017-03-15
LENSTEC, INC.
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2017-02-07
LENSTEC, INC.
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2017-01-11
LENSTEC, INC.
SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO
2016-10-20
LENSTEC, INC.
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2016-09-28
LENSTEC, INC.
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2016-09-22
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2016-03-28
LENSTEC, INC.
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2016-02-12
LENSTEC, INC.
SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS
2015-01-15
LENSTEC, INC.
THE SOFTEC HD IOL
2014-07-09
LENSTEC, INC.
SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
2014-06-16
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
2014-06-16
LENSTEC, INC.
SOFTEC INTRAOCULAR LENSES (IOLS)
2014-04-17
LENSTEC, INC.
SOFTEC HD INTRAOCULAR LENS
2013-09-19
LENSTEC, INC.
IOL DELIVERY SYSTEM
2013-07-25
LENSTEC, INC.
SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.
2013-07-03
LENSTEC, INC.
ENDOTOXIN TEST METHOD
2013-04-05
LENSTEC, INC.
SOFTEC HDO
2013-02-26
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
2013-01-29
LENSTEC, INC.
LENSTEC SOFTEC HD PCIOL
2012-09-20
LENSTEC, INC.
SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)
2012-08-16
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
2012-06-11
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2012-05-11
LENSTEC, INC.
SOFTEC HD INTRAOCULAR LENS (IOL)
2011-12-20
LENSTEC, INC.
SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL
2011-11-16
LENSTEC, INC.
SOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL
2011-09-28
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2011-09-22
LENSTEC, INC.
SOFTEC HD INTRAOCULAR LENS
2011-08-25
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2011-02-02
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTROCULAR LENS
2010-08-13
LENSTEC, INC.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2010-06-17
LENSTEC, INC.
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
2010-04-12
LENSTEC, INC.

PMN#

LENSTEC LC INJECTION SYSTEM
2013-10-18
LENSTEC, INC.
FLUID ISOLATION DEVICE
2009-10-27
LENSTEC, INC.
LENSTEC LC INJECTION SYSTEM
2007-05-07
LENSTEC, INC.
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
2006-04-14
LENSTEC, INC.
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
2005-05-31
LENSTEC, INC.