- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S022
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2023-01-31
- Decision code
- APPR
- Date received
- 2021-10-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the following modifications: 1) reducing the LDD footprint (i.e., making the LDD system more compact in a different physical configuration); 2) converting the operating system to Linux; 3) modifying the graphic user interface for better patient data entry; 4) updating the LDD work instructions based on the modified LDD; and 5) and modifications to the labeling.