AMO Manufacturing USA, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0444-2022 | Class II | Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Cataly | October 21, 2021 |
| Z-0443-2022 | Class II | iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (Uni | October 21, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223838 | Catalys Precision Laser System | April 12, 2023 |
| K220516 | CATALYS Precision Laser system | May 17, 2022 |
| K210701 | CATALYS Precision Laser System | April 7, 2021 |
| K182083 | Catalys Precision Laser System | November 9, 2018 |
| K172002 | Catalys Precision Laser System | August 25, 2017 |
| K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM | January 6, 2015 |