PMA P160055S019
- Device
- Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S019
- Product code
- PZK
- Decision date
- 2021-04-01
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- Introduction of an alternate Tyvek package heat sealer to meet increased manufacturing capacity.
Current openFDA PMA Record#
- Device
- Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S019
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2021-04-01
- Decision code
- OK30
- Date received
- 2021-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an alternate Tyvek package heat sealer to meet increased manufacturing capacity.