PMA P160055S026
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S026
- Product code
- PZK
- Decision date
- 2022-11-30
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- Addition of an alternative foil pouch sealer.
Current openFDA PMA Record#
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S026
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2022-11-30
- Decision code
- OK30
- Date received
- 2022-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative foil pouch sealer.