- Device
- Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S003
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2019-03-06
- Decision code
- APPR
- Date received
- 2018-11-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of the following sterilization vendor for the Light Adjustable Lens (LAL) and Light Delivery Device (LDD): Steris Inc. 43425 Business Park DriveTemecula, California