PMA P160055S002
- Device
- RxSight Light Adjustable Lens (LAL) and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S002
- Product code
- PZK
- Decision date
- 2019-03-04
- Classification
- Light Adjustable Lens (lal) And Light Delivery Device (ldd)
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- Approval for the post-approval study protocol, RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study, and modifications to the LAL posterior layer, the LAL haptic attachment manufacturing process, and the LDD light source, table configuration, infrared anterior segment illumination, and contact lens.
Current openFDA PMA Record#
- Device
- RxSight Light Adjustable Lens (LAL) and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S002
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2019-03-04
- Decision code
- APPR
- Date received
- 2018-09-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the post-approval study protocol, RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study, and modifications to the LAL posterior layer, the LAL haptic attachment manufacturing process, and the LDD light source, table configuration, infrared anterior segment illumination, and contact lens.