PMA P160055S039

Device: Light Adjustable Lens, Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S039
Product code: PZK
Decision date: 2024-09-03
Classification: Ophthalmic
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: approval for several cosmetic updates to LDD graphical user interface, new manufacturing service tools, and migrating camera processes to a GPU.

Current openFDA PMA Record#

Device: Light Adjustable Lens, Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S039
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2024-09-03
Decision code: APPR
Date received: 2024-06-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for several cosmetic updates to LDD graphical user interface, new manufacturing service tools, and migrating camera processes to a GPU.