PMA P160055S024

Device
Light Adjustable Lens (LAL), Light Delivery Device (LDD) System
Applicant
Rxsight, Inc.
Product code
PZK
Decision date
2023-03-31
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement
Approval for a light adjustable lens (LAL) model LAL+ as a level A modification of the optical design of the original LAL.

Current openFDA PMA Record#

Device
Light Adjustable Lens (LAL), Light Delivery Device (LDD) System
Applicant
Rxsight, Inc.
PMA number
P160055
Supplement
S024
Product code
PZK
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Decision date
2023-03-31
Decision code
APPR
Date received
2022-09-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a light adjustable lens (LAL) model LAL+ as a level A modification of the optical design of the original LAL.