PMA P160055S045

Device: LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S045
Product code: PZK
Decision date: 2025-09-02
Classification: Ophthalmic
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: approval for the professional and patient labeling to include the outcomes of the Post-approval study (PAS) LAL/LDD Postmarket RCT

Current openFDA PMA Record#

Device: LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S045
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2025-09-02
Decision code: APPR
Date received: 2025-03-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for the professional and patient labeling to include the outcomes of the Post-approval study (PAS) LAL/LDD Postmarket RCT