PMA P160055S041
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S041
- Product code
- PZK
- Decision date
- 2024-12-16
- Classification
- Ophthalmic
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- approval for an update to the A-constant in the labeling
Current openFDA PMA Record#
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S041
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2024-12-16
- Decision code
- APPR
- Date received
- 2024-10-21
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for an update to the A-constant in the labeling