PMA P160055S054

Device: RxSight Light Adjustable Lens; Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S054
Product code: PZK
Decision date: 2026-06-26
Classification: Ophthalmic
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: for a reconfiguration of the labeling approved for the Light Adjustable Lens and Light Delivery Device, and to update the content of the labeling approved for the Light Adjustable Lens and Light Delivery Device

Current openFDA PMA Record#

Device: RxSight Light Adjustable Lens; Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S054
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2026-06-26
Decision code: APPR
Date received: 2025-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: for a reconfiguration of the labeling approved for the Light Adjustable Lens and Light Delivery Device, and to update the content of the labeling approved for the Light Adjustable Lens and Light Delivery Device