Cutera, Inc.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 31
- Inspections
- 5
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0427-2014 | Class II | Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, P | October 16, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251149 | AviClear Laser System | July 11, 2025 |
| K233237 | xeo+ Family | December 15, 2023 |
| K230660 | AviClear Laser System | June 6, 2023 |
| K223110 | truSculpt iD | November 3, 2022 |
| K221407 | truSculpt iD | July 13, 2022 |
| K213461 | AviClear Laser System | March 24, 2022 |
| K182997 | enlighten III Laser System | December 12, 2018 |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | June 6, 2018 |
| K172077 | Cutera enlighten III Laser System | October 27, 2017 |
| K172004 | truSculpt | August 2, 2017 |
| K170936 | Cutera enlighten III Laser System | April 25, 2017 |
| K162512 | truSculpt | December 9, 2016 |
| K160488 | Cutera enlighten III Laser System | October 28, 2016 |
| K153671 | Family of CoolGlide Aesthetic Lasers | March 9, 2016 |
| K140727 | CUTERA PICOSECOND LASER SYSTEM | November 6, 2014 |
| K133739 | TRUSCULPT | September 5, 2014 |
| K133945 | CUTERA PICOSECOND LASER SYSTEM | August 11, 2014 |
| K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS | December 6, 2013 |
| K122493 | GENESISPLUS | May 15, 2013 |
| K122389 | TRUSCULPT | November 2, 2012 |