PMA P160055S006
- Device
- RxSight Light Adjustable Lens: Ligh Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S006
- Product code
- PZK
- Decision date
- 2019-06-20
- Classification
- Light Adjustable Lens (lal) And Light Delivery Device (ldd)
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- Use alternate manufacturing tools to manufacture the Light Adjustable Lens.
Current openFDA PMA Record#
- Device
- RxSight Light Adjustable Lens: Ligh Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S006
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2019-06-20
- Decision code
- OK30
- Date received
- 2019-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use alternate manufacturing tools to manufacture the Light Adjustable Lens.