- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S035
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2024-04-08
- Decision code
- OK30
- Date received
- 2024-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the overall size of the outer shelf-unit box and secondary shipping (foil) pouch for the RxSight LAL/LAL+ (models 60005 and 60007), and modifications to the artwork design on the shelf-unit box to reflect updated company branding and recent trademark registrations