- Device
- RxSight Light Adjustable Lens and Light Delivery System
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S014
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2021-03-17
- Decision code
- APPR
- Date received
- 2020-08-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the introduction of an alternate mixing method used in the silicone mixing process for the RxSight Light Adjustable Lens (LAL).