Data / Medical devices / United States / Lenstec, Inc.
Lenstec, Inc.: FDA-registered device maker in Saint Petersburg, FL, United States, 4 510(k) clearances and 2 PMA approvals
Lenstec, Inc. is registered with the FDA (registration 1063199) in Saint Petersburg, FL, United States. It lists 3 device types. The FDA files 4 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 22, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1063199
- FEI number
- 3001659659
- Address
- 1765 Commerce Ave N, Saint Petersburg, FL, United States, 33716
- Owner or operator
- LENSTEC, INC. (9032980)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 19, 2003
- Registered through
- 2026
- Brand names listed
- ClearView 3, IOL Injection System, LC INJECTION SYSTEM, Lenstec LC Injection System, SOFTEC IOL INJECTION SYSTEM, Softec HD Injection System, Softec HDM, Softec I and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Specification developer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2016 | K161776 | Lenstec LC Injection system | MSS | Substantially Equivalent | Lenstec, Inc. | accessdata.fda.gov |
| May 7, 2007 | K063802 | LENSTEC LC INJECTION SYSTEM | MSS | Substantially Equivalent | Lenstec, Inc. | accessdata.fda.gov |
| April 14, 2006 | K060533 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM | MSS | Substantially Equivalent | Lenstec, Inc. | accessdata.fda.gov |
| May 31, 2005 | K050638 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES | MSS | Substantially Equivalent | Lenstec, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 22, 2022 | P200020 | SBL-3 Multifocal Intraocular Lens | MFK | 11 | October 23, 2026 | accessdata.fda.gov |
| April 12, 2010 | P090022 | LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS | HQL | 42 | April 15, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Intraocular Lens
- All makers of Folders And Injectors, Intraocular Lens (Iol)
- All makers of Lens, Multifocal Intraocular
Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.