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 May 7, 2007 as substantially equivalent to K050638 (Lenstec, Inc., 2005) and 1 other predicate after a 136-day review. Its family tree reaches back 5 generations to 1994. 10 later devices descend from it.
- Decided
- May 7, 2007
- Review
- 136 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930320 (1994). 8 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 4 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 3 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 2 generations backK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- 1 generation backK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
- This deviceK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK103495 Asico Softip Injector SystemAsico, LLC · 2011
- Descendant · 2 generations on · 6 of its ownK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
- Descendant · 4 generations on · 4 of its ownK181401 RxSight Insertion DeviceRxsight, Inc. · 2018
- Descendant · 5 generations on · 3 of its ownK192926 RxSight Insertion DeviceRxsight, Inc. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K103495Asico Softip Injector SystemAsico, LLC · 2011 · cites it directly7descendants
- K142056Lioli Iol Delivery SystemAst Products, Inc. · 2015 · 2 generations on6descendants
- K172228pioli IOL Delivery SystemAst Products, Inc. · 2017 · 3 generations on5descendants
- K181401RxSight Insertion DeviceRxsight, Inc. · 2018 · 4 generations on4descendants
- K192926RxSight Insertion DeviceRxsight, Inc. · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −4 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −3 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −2 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| −1 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
| 0 (this device) | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| +1 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| +2 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
| +3 | K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017 | — |
| +4 | K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018 | — |
| +5 | K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular LensesSummary page 2…SS, 886.4300) 3. Substantially Equivalent legally-marketed devices: a. Lenstec Injection System for Tetraflex Intraocular lenses (K050638) b. Lenstec Injection System for Softec Injection System (K060533) 4. Device Description The system consists o… | 2005 |
| * | K060533 | Lenstec Intraocular Lens (Iol) Injection SystemSummary page 2…gally-marketed devices: a. Lenstec Injection System for Tetraflex Intraocular lenses (K050638) b. Lenstec Injection System for Softec Injection System (K060533) 4. Device Description The system consists of the following components: Cartridge Injector… | 2006 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K103495 (Asico, LLC, 2011) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K050638.
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. 2007, 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?
The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063802 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063802: Lenstec LC Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063802
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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