FDA.reportPublic FDA data

PMA P160055S032

Device
Light Adjustable Lens, Light Delivery Device
Applicant
Rxsight, Inc.
PMA number
P160055
Supplement
S032
Product code
PZK
Decision date
2023-10-24
Classification
Ophthalmic
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement
the addition of an alternate anterior layer silicone material mixing method used during manufacturing of the RxSight Intraocular Lenses (IOL)(parent LAL model 60005 and the LAL+ model 60007)

Current openFDA PMA Record#

Device
Light Adjustable Lens, Light Delivery Device
Applicant
Rxsight, Inc.
PMA number
P160055
Supplement
S032
Product code
PZK
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Decision date
2023-10-24
Decision code
OK30
Date received
2023-09-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the addition of an alternate anterior layer silicone material mixing method used during manufacturing of the RxSight Intraocular Lenses (IOL)(parent LAL model 60005 and the LAL+ model 60007)