RxSight Light Adjustable Lens and Light Delivery Device
FDA premarket approval P160055/S011 · decided 2020-05-21
Approval details
- PMA number
- P160055
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RxSight Light Adjustable Lens and Light Delivery Device
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Applicant
- Rxsight, Inc.
- Date received
- 2020-02-27
- Decision date
- 2020-05-21
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- PZK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for the software modifications for Light Delivery Device (LDD) system: (1) Update to allow patient data to be entered and saved prior to treatment session; (2) Update to treatment Summary report format to include 2D barcode, in addition to text File; (3) Update GUI (graphical user interface) display; and (4) Update to the self-test routine to include additional confirmation of power reading prior to treatment.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
| RxSight® Insertion Device (63002) (K231838) | Rxsight, Inc. | 2023-08-15 |
| RxSight Insertion Device (K231466) | Rxsight, Inc. | 2023-06-12 |
| RxSight Contact Lens (K201909) | Rxsight, Inc. | 2020-09-10 |
| RxSight Insertion Device (K192926) | Rxsight, Inc. | 2020-01-17 |
| RxSight Insertion Device (K181401) | Rxsight, Inc. | 2018-07-26 |