PMA P160055S037
- Device
- Light Adjustable Lens and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S037
- Product code
- PZK
- Decision date
- 2024-12-02
- Classification
- Ophthalmic
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Approval order statement
- approval to receive incoming material from an alternate supplier manufacturing site
Current openFDA PMA Record#
- Device
- Light Adjustable Lens and Light Delivery Device
- Applicant
- Rxsight, Inc.
- PMA number
- P160055
- Supplement
- S037
- Product code
- PZK
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Decision date
- 2024-12-02
- Decision code
- APPR
- Date received
- 2024-03-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to receive incoming material from an alternate supplier manufacturing site