PMA P160055S046
- Device
- Light Adjustable Lens, Light Delivery System
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S046
- Product code
- PZK
- Decision date
- 2025-06-11
- Classification
- Ophthalmic
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- approval for minor design modifications of an optical assembly inside the Light Delivery Device Model 61002-007
Current openFDA PMA Record#
- Device
- Light Adjustable Lens, Light Delivery System
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S046
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2025-06-11
- Decision code
- APPR
- Date received
- 2025-03-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for minor design modifications of an optical assembly inside the Light Delivery Device Model 61002-007