FDA.reportPublic FDA data

PMA P160055S018

Device
RxSight Light Adjustable Lens and Light Delivery Device
Applicant
Rxsight, Inc.
PMA number
P160055
Supplement
S018
Product code
PZK
Decision date
2021-03-19
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement
Addition of a second source supplier for a contact lens accessory used with the LDD and an expansion of the contact lens accessory packaging to hold three devices.

Current openFDA PMA Record#

Device
RxSight Light Adjustable Lens and Light Delivery Device
Applicant
Rxsight, Inc.
PMA number
P160055
Supplement
S018
Product code
PZK
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Decision date
2021-03-19
Decision code
OK30
Date received
2021-02-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a second source supplier for a contact lens accessory used with the LDD and an expansion of the contact lens accessory packaging to hold three devices.