- Device
- LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S047
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2025-05-02
- Decision code
- OK30
- Date received
- 2025-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the primary lens case packaging for the Light Adjustable Lens (LAL) and LAL+ intraocular lens devices