PMA P160055S028
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S028
- Product code
- PZK
- Decision date
- 2023-06-29
- Classification
- Ophthalmic
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- Approval for updates to LDD user interface, user settings, and diagnostic routings along with minor bug fixes.
Current openFDA PMA Record#
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S028
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2023-06-29
- Decision code
- APPR
- Date received
- 2023-04-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to LDD user interface, user settings, and diagnostic routings along with minor bug fixes.