PMA P160055S048
- Device
- Light Adjustable Lens and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S048
- Product code
- PZK
- Decision date
- 2025-05-12
- Classification
- Ophthalmic
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- a change to the manufacturing location of the macromer used in the RxSight Light Adjustable Lenses
Current openFDA PMA Record#
- Device
- Light Adjustable Lens and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S048
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2025-05-12
- Decision code
- OK30
- Date received
- 2025-04-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the manufacturing location of the macromer used in the RxSight Light Adjustable Lenses