PMA P930016S066
- Device
- iDesign Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- Product code
- LZS
- Decision date
- 2024-03-22
- Generic name
- Excimer laser system
- Approval order statement
- expansion of the labeling temperature and humidity range specifications for shipping and storage
Current openFDA PMA Record#
- Device
- iDesign Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S066
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2024-03-22
- Decision code
- APPR
- Date received
- 2023-12-06
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- expansion of the labeling temperature and humidity range specifications for shipping and storage