PMA P160055S051

Device: RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD)
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S051
Product code: PZK
Decision date: 2025-07-14
Classification: Ophthalmic
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: addition of an alternate supplier for the silicone resin, a raw precursor material of the RxSight Light Adjustable Lenses (LAL/LAL+)

Current openFDA PMA Record#

Device: RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD)
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S051
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2025-07-14
Decision code: OK30
Date received: 2025-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternate supplier for the silicone resin, a raw precursor material of the RxSight Light Adjustable Lenses (LAL/LAL+)