PMA P160055S008
- Device
- Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S008
- Product code
- PZK
- Decision date
- 2019-11-22
- 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 additional qualified coupling agents and UV protective eyewear to be used with the LAL/LDD.
Current openFDA PMA Record#
- Device
- Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S008
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2019-11-22
- Decision code
- APPR
- Date received
- 2019-09-13
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for additional qualified coupling agents and UV protective eyewear to be used with the LAL/LDD.