- Device
- RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S029
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2023-05-18
- Decision code
- OK30
- Date received
- 2023-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Option to sterilize the Light Adjustable Lens (LAL) device a second time by Ethylene Oxide (2x EO sterilization).