RxSight Inc.
Aliso Viejo, CA, US
RxSight Inc. appears in FDA device records in Aliso Viejo, CA. FDA records list 6 510(k) clearances between and , 47 PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for RxSight Inc. between 2018 and 2026. The busiest year on record is 2020, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 2 |
| 2023 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261174 | RxSight® Insertion Device | MSS | Substantially Equivalent | |
| K231838 | RxSight® Insertion Device (63002) | MSS | Substantially Equivalent | |
| K231466 | RxSight Insertion Device | MSS | Substantially Equivalent | |
| K201909 | RxSight Contact Lens | HJK | Substantially Equivalent | |
| K192926 | RxSight Insertion Device | MSS | Substantially Equivalent | |
| K181401 | RxSight Insertion Device | MSS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012712027 | 3012712027 | RxSight Inc. | 100 Columbia, Aliso Viejo, CA 92656 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain