PMA P160055S004
- Device
- RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S004
- Product code
- PZK
- Decision date
- 2019-04-05
- Classification
- Light Adjustable Lens (lal) And Light Delivery Device (ldd)
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- Expansion of the manufacturing to an additional building under the same FDA establishment registration, addition of a large humidity chamber, and a modification to the optic surface molds.
Current openFDA PMA Record#
- Device
- RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S004
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2019-04-05
- Decision code
- OK30
- Date received
- 2019-03-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of the manufacturing to an additional building under the same FDA establishment registration, addition of a large humidity chamber, and a modification to the optic surface molds.