Bellus Medical
FDA Regulatory Profile
Bellus Medical appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0660-2020, Class II) was initiated on January 18, 2019. Its most recent 510(k) clearance was granted on March 1, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0660-2020 | Class II | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Resc | January 18, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN160029 | SkinPen Precision System | March 1, 2018 |