PMA P160055S044

Device: Light Adjustable Lens and Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S044
Product code: PZK
Decision date: 2025-05-19
Classification: Ophthalmic
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: Approval for updates to the Light Delivery Device (LDD) – Model 61002-006 software that include changes to the graphical user interface (GUI), non-user facing manufacturing and service software tools, software processing improvements as well as bug fixes.

Current openFDA PMA Record#

Device: Light Adjustable Lens and Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S044
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2025-05-19
Decision code: APPR
Date received: 2025-02-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to the Light Delivery Device (LDD) – Model 61002-006 software that include changes to the graphical user interface (GUI), non-user facing manufacturing and service software tools, software processing improvements as well as bug fixes.