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 Jun 10, 2026 as substantially equivalent to K231466 (Rxsight, Inc., 2023) and 1 other predicate after a 62-day review. Its family tree reaches back 13 generations to 1994.
- Decided
- Jun 10, 2026
- Review
- 62 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K930320 (1994). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 9 generations between
- 3 generations backK192926 RxSight Insertion DeviceRxsight, Inc. · 2020
- 2 generations backK231466 RxSight Insertion DeviceRxsight, Inc. · 2023
- 1 generation backK231838 RxSight® Insertion Device (63002)Rxsight, Inc. · 2023
- This deviceK261174 RxSight® Insertion DeviceRxsight, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 12 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 11 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 10 generations backK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- 9 generations backK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
- 8 generations backK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- 7 generations backK103495 Asico Softip Injector SystemAsico, LLC · 2011
- 6 generations backK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- 5 generations backK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
- 4 generations backK181401 RxSight Insertion DeviceRxsight, Inc. · 2018
- 3 generations backK192926 RxSight Insertion DeviceRxsight, Inc. · 2020
- 2 generations backK231466 RxSight Insertion DeviceRxsight, Inc. · 2023
- 1 generation backK231838 RxSight® Insertion Device (63002)Rxsight, Inc. · 2023
- This deviceK261174 RxSight® Insertion DeviceRxsight, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −12 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −11 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −10 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| −9 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
| −8 | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| −7 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| −6 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
| −5 | K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017 | — |
| −4 | K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018 | — |
| −3 | K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020 | — |
| −2 | K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023 | — |
| −1 | K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 K231466 RxSight Insertion Devicescore 14.5 · 11 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 |
|---|---|---|---|
| * | K231466 | RxSight Insertion DeviceSummary page 5…(IOL) DEVICE CLASSIFICATION: Class I; 21 CFR 886.4300 PRODUCT CODE: MSS PREDICATE DEVICE: RxSight Insertion Device cleared in K231466 and K231838 Device Description The RxSight Insertion Device (Model 63000/63001) is a two-part intraocular lens (IOL) injector d… | 2023 |
| * | K231838 | RxSight® Insertion Device (63002)Summary page 5…DEVICE CLASSIFICATION: Class I; 21 CFR 886.4300 PRODUCT CODE: MSS PREDICATE DEVICE: RxSight Insertion Device cleared in K231466 and K231838 Device Description The RxSight Insertion Device (Model 63000/63001) is a two-part intraocular lens (IOL) injector device compri… | 2023 |
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 32 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K231466.
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. 2026, 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 intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+(TM), and IOL models validated for use with this device in IOL approved labeling.
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/K261174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261174: 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/K261174
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026