ProSun International, LLC
FDA Regulatory Profile
ProSun International, LLC appears in FDA public data with 3 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1177-2019, Class II) was initiated on December 10, 2018. Its most recent 510(k) clearance was granted on September 10, 2018.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1177-2019 | Class II | ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 H | December 10, 2018 |
| Z-1176-2019 | Class II | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN | December 10, 2018 |
| Z-0319-2018 | Class II | Sundream 12 V tanning bed | December 2, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K181455 | ProSun sunlamp products, Luxura sunlamp products | September 10, 2018 |