510(k) · Cleared
ClearedLenstec LC Injection system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lenstec, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Nov 29, 2016 as substantially equivalent to K122848 (Lenstec, Inc., 2013) after a 153-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Nov 29, 2016
- Review
- 153 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930320 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 6 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 5 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 4 generations backK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- 3 generations backK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
- 2 generations backK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- 1 generation backK122848 Lenstec LC Injection SystemLenstec, Inc. · 2013
- This deviceK161776 Lenstec LC Injection systemLenstec, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −6 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −5 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −4 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| −3 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
| −2 | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| −1 | K122848 | Lenstec LC Injection System | Lenstec, Inc. | 2013 | — |
| 0 (this device) | K161776 | Lenstec LC Injection system | Lenstec, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSS device
- #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122848 | Lenstec LC Injection SystemSummary page 4…f. Regulation number: 21 CFR 886.4300 3. Substantially Equivalent legally-marketed device: a. Lenstec Injection System for Intraocular Lens delivery (K122848) 36 4. Device D… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All MSS devicesMSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MSS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSS
54in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSS
429in 2025
MAUDE reports naming product code MSS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 445 |
| 2008 | 5 | 84 | 0 | 185 |
| 2009 | 5 | 197 | 0 | 186 |
| 2010 | 2 | — | 0 | 203 |
| 2011 | 2 | — | 0 | 95 |
| 2012 | 2 | — | 0 | 129 |
| 2013 | 5 | 141 | 0 | 203 |
| 2014 | 5 | 78 | 0 | 114 |
| 2015 | 3 | 156 | 0 | 127 |
| 2016 | 2 | — | 1 | 112 |
| 2017 | 3 | 30 | 1 | 114 |
| 2018 | 1 | — | 0 | 340 |
| 2019 | 3 | 67 | 0 | 271 |
| 2020 | 2 | — | 0 | 362 |
| 2021 | 1 | — | 0 | 289 |
| 2022 | 0 | — | 0 | 490 |
| 2023 | 3 | 54 | 0 | 330 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 1 | — | 0 | 429 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Lenstec’s LC Injection System is intended for use in the implantation of the Softec HD, Softec I, Softec HDO, Softec HDM and any approved IOL in which the labeling specifies use of this injector (s) to insert the lens into the capsular bag following extracapsular extraction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161776 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161776: Lenstec LC Injection system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161776
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026