Lenstec Inc

FDA Filings

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

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

• LENSTEC BARBADOS, INC.

FDA Registration(s)

• Registration Number: 9613160
• FEI Number: 3001284430
• Name: LENSTEC BARBADOS, INC.
• Owner & Operator: LENSTEC, INC.
• Contact Address: 1765 Commerce Ave N --; Saint Petersburg FL 33716 US
• Official Correspondent:
  • JIMMY - CHACKO
  • x-727-5712272-x
• US Agent:
  • JIMMY - CHACKO
  • LENSTEC, INC.
  • 727 5712272
  • 727 5711792
  • jchacko@lenstec.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: AIRPORT COMMERCIAL CENTRE PILGRIM ROAD; CHRIST CHURCH Christ Church, BB 17092 BB
• Establishment Type: Manufacture Medical Device

• Registration Number: 1063199
• FEI Number: 3001659659
• Name: LENSTEC, INC.
• Owner & Operator: LENSTEC, INC.
• Contact Address: 1765 Commerce Ave N --; Saint Petersburg FL 33716 US
• Official Correspondent:
  • JIMMY - CHACKO
  • x-727-5712272-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1765 Commerce Ave N ; Saint Petersburg, FL 33716 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P090022S039 LENSTEC, INC.	Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM	2021-09-28
PMA P090022S038 LENSTEC, INC.	Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs	2021-01-07
PMA P090022S037 LENSTEC, INC.	Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs	2020-10-23
PMA P090022S036 LENSTEC, INC.	Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs	2020-10-15
PMA P090022S035 LENSTEC, INC.	Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs	2018-09-06
PMN K161776 | MSS LENSTEC, INC.	Lenstec LC Injection System	2017-10-27
PMN K161776 | MSS LENSTEC BARBADOS, INC. [LENSTEC, INC.]	Lenstec LC Injection System	2017-10-27
PMA P090022S034 LENSTEC, INC.	Lenstec Softec HD aspheric posterior chamber intraocular lens	2017-06-05
PMA P090022S032 LENSTEC, INC.	Lenstec Softec HD Posterior Chamber Intraocular Lens	2017-03-15
PMA P090022S031 LENSTEC, INC.	LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2017-02-07
PMA P090022S030 LENSTEC, INC.	LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2017-01-11
PMN K161776 LENSTEC INC.	Lenstec LC Injection System	2016-11-29
PMA P090022S025 LENSTEC, INC.	SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO	2016-10-20
PMA P090022S029 LENSTEC, INC.	LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2016-09-28
PMA P090022S028 LENSTEC, INC.	LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2016-09-22
PMA P090022S026 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2016-03-28
PMA P090022S027 LENSTEC, INC.	LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2016-02-12
PMA P090022S024 LENSTEC, INC.	SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS	2015-01-15
PMA P090022S023 LENSTEC, INC.	THE SOFTEC HD IOL	2014-07-09
PMA P090022S022 LENSTEC, INC.	SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)	2014-06-16
PMA P090022S020 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)	2014-06-16
PMA P090022S021 LENSTEC, INC.	SOFTEC INTRAOCULAR LENSES (IOLS)	2014-04-17
PMN K122848 | MSS LENSTEC BARBADOS, INC. [LENSTEC, INC.]	Lenstec LC Injection System	2013-12-12
PMN K122848 LENSTEC, INC.	LENSTEC LC INJECTION SYSTEM	2013-10-18
PMA P090022S019 LENSTEC, INC.	SOFTEC HD INTRAOCULAR LENS	2013-09-19
PMA P090022S017 LENSTEC, INC.	IOL DELIVERY SYSTEM	2013-07-25
PMA P090022S018 LENSTEC, INC.	SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.	2013-07-03
PMA P090022S016 LENSTEC, INC.	ENDOTOXIN TEST METHOD	2013-04-05
PMA P090022S015 LENSTEC, INC.	SOFTEC HDO	2013-02-26
PMA P090022S012 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)	2013-01-29
PMA P090022S014 LENSTEC, INC.	LENSTEC SOFTEC HD PCIOL	2012-09-20
PMA P090022S013 LENSTEC, INC.	SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)	2012-08-16
PMA P090022S011 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)	2012-06-11
PMA P090022S010 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2012-05-11
PMA P090022S007 LENSTEC, INC.	SOFTEC HD INTRAOCULAR LENS (IOL)	2011-12-20
PMA P090022S009 LENSTEC, INC.	SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL	2011-11-16
PMA P090022S008 LENSTEC, INC.	SOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL	2011-09-28
PMA P090022S005 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2011-09-22
PMA P090022S006 LENSTEC, INC.	SOFTEC HD INTRAOCULAR LENS	2011-08-25
PMA P090022S004 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2011-02-02
PMA P090022S002 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTROCULAR LENS	2010-08-13
PMA P090022S001 LENSTEC, INC.	SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2010-06-17
PMN P090022 | HQL LENSTEC, INC.	Softec HD IOL	2010-04-23
PMN P090022 | HQL LENSTEC BARBADOS, INC. [LENSTEC, INC.]	Softec HD IOL	2010-04-23
PMN K063802 | MSS LENSTEC, INC.	IOL Injection System	2010-04-23
PMN K063802 | MSS LENSTEC BARBADOS, INC. [LENSTEC, INC.]	IOL Injection System	2010-04-23
PMN K060533 | MSS LENSTEC, INC.	Softec HD Injection System	2010-04-23
PMN K060533 | MSS LENSTEC BARBADOS, INC. [LENSTEC, INC.]	Softec HD Injection System	2010-04-23
PMA P090022 LENSTEC, INC.	LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS	2010-04-12
PMN K091915 LENSTEC, INC.	FLUID ISOLATION DEVICE	2009-10-27
PMN K063802 LENSTEC, INC.	LENSTEC LC INJECTION SYSTEM	2007-05-07
PMN K060533 LENSTEC, INC.	LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM	2006-04-14
PMN K050638 LENSTEC, INC.	LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES	2005-05-31
PMN K050638 | MSS LENSTEC, INC.	TETRAFLEX IOL INJECTION SYSTEM	2003-03-19
PMN K050638 | MSS LENSTEC, INC.	SOFTEC IOL INJECTION SYSTEM	2003-03-19
PMN K050638 | MSS LENSTEC, INC.	LC INJECTION SYSTEM	2003-03-19
PMN K050638 | MSS LENSTEC BARBADOS, INC. [LENSTEC, INC.]	TETRAFLEX IOL INJECTION SYSTEM	2003-03-19
PMN K050638 | MSS LENSTEC BARBADOS, INC. [LENSTEC, INC.]	SOFTEC IOL INJECTION SYSTEM	2003-03-19
PMN K050638 | MSS LENSTEC BARBADOS, INC. [LENSTEC, INC.]	LC INJECTION SYSTEM	2003-03-19

Similar & Related FDA Registered Companies

• Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS002 Date Received10/20/2022 Decision Date11/17/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS001 Date Received08/18/2022 Decision Date09/16/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Date Received03/16/2020 Decision Date07/22/2022 Product Code MFK  Advisory Committee Ophthalmic Clinical TrialsNCT02487160 Expedited Review Granted? No
• Lenstec Barbados Inc

Related Finance Registrations

NCAGE Code	55M57	LENSTEC INC
NCAGE Code	6FMV1	LENSTEC, INC.
CAGE Code	55M57	LENSTEC INC
CAGE Code	6FMV1	LENSTEC, INC.
S.A.M. Registration	6FMV1 [807554100]	LENSTEC, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020032136593	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	LIDSTOCK CX79 POLYPROPYLENE	7 PKG
2020031745439	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	LIDSTOCK CX79 POLYPROPYLENE	7 PKG