FDA.reportPublic FDA data

PMA P160055S016

Device
RxSight Light Adjustable Lens and Light Delivery Device
Applicant
Rxsight, Inc.
PMA number
P160055
Supplement
S016
Product code
PZK
Decision date
2021-02-19
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement
Approval for modifications of the Professional Use labeling to include the RxSight Insertion Device as a method for introducing the Light Absorbable Lens (LAL) into the eye, along with other minor changes.

Current openFDA PMA Record#

Device
RxSight Light Adjustable Lens and Light Delivery Device
Applicant
Rxsight, Inc.
PMA number
P160055
Supplement
S016
Product code
PZK
Generic name
Light adjustable lens (LAL) and light delivery device (LDD)
Decision date
2021-02-19
Decision code
APPR
Date received
2020-11-27
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for modifications of the Professional Use labeling to include the RxSight Insertion Device as a method for introducing the Light Absorbable Lens (LAL) into the eye, along with other minor changes.