Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063199

FEI Number

3001659659

Entity Name

LENSTEC, INC.

City/State/Country

Saint Petersburg, FL, US

Establishment Address

1765 Commerce Ave N, Saint Petersburg, FL 33716, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

LENSTEC, INC. (Owner Number: 9032980)

Owner / Operator Contact Address

1765 Commerce Ave N, --, Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063802

PMA Number

N/A

All Registered Proprietary Names

Softec HDM Softech HDO Softec I Lenstec LC Injection System TETRAFLEX IOL INJECTION SYSTEM LC INJECTION SYSTEM SOFTEC IOL INJECTION SYSTEM IOL Injection System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2010-04-23
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2017-10-27
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2003-03-19
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2010-04-23

Official Correspondent

JIMMY CHACKO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LENSTEC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9613160	LENSTEC BARBADOS, INC.	CHRIST CHURCH, BB

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0275-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0276-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0605-2010	Abbott Medical Optics Inc (AMO)	3	AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Z-0929-2013	Abbott Medical Optics Inc (AMO)	3	AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Z-2287-2020	Alcon Research LLC Aspex Facility	3	Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063199. Last updated year: 2026. Please use registration number 1063199 when referencing this establishment in official correspondence.