Rxsight, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Rxsight, Inc.” (first 2018, latest 2026), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 60 days, against 60 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 58 |
| 2019 | 0 | — |
| 2020 | 2 | 78 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 39 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 62 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rxsight, Inc. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 60 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 5 | 5 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 1 | 1 |
| PZK | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | 1 | 0 |
Review panels
- Ophthalmic (7)
Most recent Rxsight, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261174 | RxSight® Insertion Device | MSS | 2026-06-10 | 62 |
| K231838 | RxSight® Insertion Device (63002) | MSS | 2023-08-15 | 54 |
| K231466 | RxSight Insertion Device | MSS | 2023-06-12 | 24 |
| K201909 | RxSight Contact Lens | HJK | 2020-09-10 | 63 |
| K192926 | RxSight Insertion Device | MSS | 2020-01-17 | 93 |
| K181401 | RxSight Insertion Device | MSS | 2018-07-26 | 58 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160055 | PMA | LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) | 2017-11-22 |
Recalls
openFDA lists no recalls under a recalling firm named Rxsight, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Rxsight, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07347379: Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study (Enrolling by invitation, started 2025-11-13)
- NCT05202808: RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study (Completed, started 2021-12-03)
- NCT04529616: Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes (Completed, started 2020-05-22)
- NCT04005586: A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL) (Completed, started 2019-07-01)
- NCT03660865: Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery (Completed, started 2018-08-28)
SEC filings
RxSight, Inc. (RXST): EDGAR filings, CIK 1111485. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rxsight, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Rxsight, Inc.” (first 2018, latest 2026), plus 1 PMA decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rxsight, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rxsight, Inc. is 60 days. Since 2017: 60 days, versus 60 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rxsight, Inc.?
The most frequent FDA product codes under this applicant name are MSS (Folders And Injectors, Intraocular Lens (Iol), 5); HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic, 1); PZK (Light Adjustable Lens (Lal) And Light Delivery Device (Ldd), 1).
Next steps
- See all 6 Rxsight, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MSS, Rxsight, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.