- Device
- RxSight Light Adjustable Lens and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S011
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2020-05-21
- Decision code
- APPR
- Date received
- 2020-02-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.