Lenstec, Inc.: FDA clearances and approvals
Lenstec, Inc. has 6 FDA 510(k) clearances (first 2005, latest 2016), plus 2 PMA decisions, across 4 product codes in 1 review panel. Median 510(k) review time: 128 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 395 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 153 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 5 | 5 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| HQL | Intraocular Lens | 1 | 0 |
| MFK | Lens, Multifocal Intraocular | 1 | 0 |
Review panels
- Ophthalmic (8)
Most recent Lenstec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161776 | Lenstec LC Injection system | MSS | 2016-11-29 | 153 |
| K122848 | LENSTEC LC INJECTION SYSTEM | MSS | 2013-10-18 | 395 |
| K091915 | FLUID ISOLATION DEVICE | HQC | 2009-10-27 | 119 |
| K063802 | LENSTEC LC INJECTION SYSTEM | MSS | 2007-05-07 | 136 |
| K060533 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM | MSS | 2006-04-14 | 45 |
| K050638 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES | MSS | 2005-05-31 | 81 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200020 | PMA | SBL-3 Multifocal Intraocular Lens | 2022-07-22 |
| P090022 | PMA | LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS | 2010-04-12 |
Recalls
openFDA lists no recalls under a recalling firm named Lenstec, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Lenstec, Inc. have?
Lenstec, Inc. has 6 FDA 510(k) clearances (first 2005, latest 2016), plus 2 PMA decisions, across 4 product codes in 1 review panel.
How long does FDA take to clear Lenstec, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lenstec, Inc.'s cleared 510(k)s is 128 days.
What devices does Lenstec, Inc. make?
Its most frequent FDA product codes are MSS (Folders And Injectors, Intraocular Lens (Iol), 5); HQC (Unit, Phacofragmentation, 1); HQL (Intraocular Lens, 1).
Has Lenstec, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lenstec, Inc. Related entities may recall under other names.
Next steps
- See all 6 Lenstec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MSS, Lenstec, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.