510(k) · Cleared
ClearedRxSight Insertion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rxsight, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jul 26, 2018 as substantially equivalent to K151102 (Bausch & Lomb, Inc., 2015) and 1 other predicate after a 58-day review. Its family tree reaches back 9 generations to 1994. 4 later devices descend from it.
- Decided
- Jul 26, 2018
- Review
- 58 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930320 (1994). 19 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 5 generations between
- 3 generations backK103495 Asico Softip Injector SystemAsico, LLC · 2011
- 2 generations backK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- 1 generation backK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
- This deviceK181401 RxSight Insertion DeviceRxsight, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK192926 RxSight Insertion DeviceRxsight, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK231466 RxSight Insertion DeviceRxsight, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK231838 RxSight® Insertion Device (63002)Rxsight, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK261174 RxSight® Insertion DeviceRxsight, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 8 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 7 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 6 generations backK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- 5 generations backK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
- 4 generations backK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- 3 generations backK103495 Asico Softip Injector SystemAsico, LLC · 2011
- 2 generations backK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- 1 generation backK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
- This deviceK181401 RxSight Insertion DeviceRxsight, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K192926RxSight Insertion DeviceRxsight, Inc. · 2020 · cites it directly3descendants
- K231466RxSight Insertion DeviceRxsight, Inc. · 2023 · 2 generations on2descendants
- K231838RxSight® Insertion Device (63002)Rxsight, Inc. · 2023 · 3 generations on1descendant
- K261174RxSight® Insertion DeviceRxsight, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −8 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −7 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −6 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| −5 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
| −4 | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| −3 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| −2 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
| −1 | K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017 | — |
| 0 (this device) | K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018 | — |
| +1 | K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020 | — |
| +2 | K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023 | — |
| +3 | K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023 | — |
| +3 | K261174 | RxSight® Insertion Device | Rxsight, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K151102 | Bausch + Lomb Injector SystemSummary page 4…rs and Injectors, Intraocular Lens (IOL) DEVICE CLASSIFICATION: Class I; 21 CFR 886.4300 PRODUCT CODE: MSS PREDICATE DEVICES: K151102, Bausch + Lomb Injector System K172228, pioli™ IOL Delivery System 1.1 DEVICE DESCRIPTION… | 2015 |
| * | K172228 | pioli IOL Delivery SystemSummary page 4…ass I; 21 CFR 886.4300 PRODUCT CODE: MSS PREDICATE DEVICES: K151102, Bausch + Lomb Injector System K172228, pioli™ IOL Delivery System 1.1 DEVICE DESCRIPTION The RxSight Insertion Device is a two-part IOL injector device comprised… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192926 | RxSight Insertion Device | 2020 | 3 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K192926 (Rxsight, Inc., 2020) has gone furthest, with 3 descendants of its own.
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. 2018, 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 RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is only for the insertion of the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181401: RxSight Insertion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181401
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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