- Device
- Light Adjustable Lens and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S052
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2025-10-08
- Decision code
- APPR
- Date received
- 2025-07-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the Light Delivery Device (LDD) Model 61002-006 software and Model 61002-007 software that include minor enhancements to the graphical user interface (GUI), improvements to internal manufacturing and service tools, software processing optimizations, and resolution of identified bugs