Data / Medical devices / United States / RxSight Inc.
RxSight Inc.: FDA-registered device maker in Aliso Viejo, CA, United States, 3 510(k) clearances and 1 PMA approval
RxSight Inc. is registered with the FDA (registration 3012712027) in Aliso Viejo, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated August 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012712027
- Address
- 100 Columbia, Aliso Viejo, CA, United States, 92656
- Owner or operator
- RxSight Inc. (10028051)
- Roles
- Manufacturer
- First device listed
- November 27, 2017
- Registered through
- 2026
- Brand names listed
- Contrast Card, RxSigfht Injector Cartridge and RxSight Injector Handpiece, RxSight Contact Lens, RxSight Insertion Device, RxSight Light Adjustable Lens (LAL+), RxSight Light Adjustable Lens (RxLAL), RxSight Light Delivery Device (LDD), RxSight Post Operative Spectacles
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chart, Visual Acuity | HOX | 1 | Manufacturer | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Manufacturer | accessdata.fda.gov |
| Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | PZK | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 15, 2023 | K231838 | RxSight® Insertion Device (63002) | MSS | Substantially Equivalent | Rxsight, Inc. | accessdata.fda.gov |
| June 12, 2023 | K231466 | RxSight Insertion Device | MSS | Substantially Equivalent | Rxsight, Inc. | accessdata.fda.gov |
| September 10, 2020 | K201909 | RxSight Contact Lens | HJK | Substantially Equivalent | Rxsight, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 22, 2017 | P160055 | LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) | PZK | 48 | October 22, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Chart, Visual Acuity
- All makers of Lens, Contact, Polymethylmethacrylate, Diagnostic
- All makers of Folders And Injectors, Intraocular Lens (Iol)
Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.