510(k) · Cleared
ClearedRxSight Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rxsight, Inc. · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Cleared on Sep 10, 2020 as substantially equivalent to K872136 (Ocular Instruments, Inc., 1987) after a 63-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Sep 10, 2020
- Review
- 63 days
- Class
- Class II
- Product code
- HJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872136 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872136 12.5MM Peyman Wide Field Yag Laser LensOcular Instruments, Inc. · 1987
- This deviceK201909 RxSight Contact LensRxsight, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872136 | 12.5MM Peyman Wide Field Yag Laser Lens | Ocular Instruments, Inc. | 1987 | — |
| 0 (this device) | K201909 | RxSight Contact Lens | Rxsight, Inc. | 2020 | — |
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 HJK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K872136 | 12.5MM Peyman Wide Field Yag Laser LensSummary page 4…6.1385 PRODUCT CODE: HJK PREDICATE DEVICE: Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens, K872136 DEVICE DESCRIPTION The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and t… | 1987 |
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?
- Its one ancestor has no recall.
How does its category compare?
All HJK devicesHJK Lens, Contact, Polymethylmethacrylate, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HJK
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HJK
Too few HJK 510(k)s in any year since 2007 to give a median.
Recalls per year · HJK
No recall names HJK since 2007.
Adverse event reports per year · HJK
1in 2025
MAUDE reports naming product code HJK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RxSight Contact Lens is indicated for visualization and treatment in the anterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201909: RxSight Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201909
Report an extraction error
Are you the manufacturer?
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