PMA P160055S015

Device: RxSight Light Adjustable Lens and Light Delivery Device
Applicant: Rxsight, Inc.
Product code: PZK
Decision date: 2021-04-20
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: Approval for (1) a simplified fixed output beam aperture in place of the current motorized aperture, (2) update to LDD lock-in treatment profile to reduce ocular exposure, (3) update to the Windows 10 operating system, (4) extension of dioptric power range to include +4.0 to +9.0 diopters, (5) introduce an additional UV-A absorber to the anterior portion of the LAL, and (6) updates to manufacturing work instructions, LDD Graphical User Interface (GUI), and user labeling to reflect all modifications.

Current openFDA PMA Record#

Device: RxSight Light Adjustable Lens and Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S015
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2021-04-20
Decision code: APPR
Date received: 2020-10-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for (1) a simplified fixed output beam aperture in place of the current motorized aperture, (2) update to LDD lock-in treatment profile to reduce ocular exposure, (3) update to the Windows 10 operating system, (4) extension of dioptric power range to include +4.0 to +9.0 diopters, (5) introduce an additional UV-A absorber to the anterior portion of the LAL, and (6) updates to manufacturing work instructions, LDD Graphical User Interface (GUI), and user labeling to reflect all modifications.