PMA P160055S021
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S021
- Product code
- PZK
- Decision date
- 2021-10-05
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Light Adjustable Lens, Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S021
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2021-10-05
- Decision code
- APPR
- Date received
- 2021-09-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.