PMA P160055S040

Device: Light Adjustable Lens, Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S040
Product code: PZK
Decision date: 2024-10-31
Classification: Ophthalmic
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: approval for minor updates to Light Delivery Device (LDD) – Model 61002-006 graphical user interface, service tools, and CPU processing.

Current openFDA PMA Record#

Device: Light Adjustable Lens, Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S040
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2024-10-31
Decision code: APPR
Date received: 2024-08-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for minor updates to Light Delivery Device (LDD) – Model 61002-006 graphical user interface, service tools, and CPU processing.