- Device
- Light Adjustable Lens and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S038
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2024-07-29
- Decision code
- APPR
- Date received
- 2024-05-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for an extension of the spherical refractive power range of -2.0 to +3.0 D in one diopter (D) increments for the Light Adjustable Lens (LAL) model LAL+ intraocular lens (IOL) for use with the Light Delivery Device (LDD) model 61002-007