Daavlin Distributing Company
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 18
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1074-2022 | Class II | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3 | April 26, 2022 |
| Z-1073-2022 | Class II | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3 | April 26, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233811 | DT Controlled Phototherapy Equipment | December 13, 2023 |
| K230382 | 3 Series NeoLux | March 24, 2023 |
| K220840 | 1 Series Phototherapy Equipment | April 22, 2022 |
| K212510 | 7 Series Phototherapy Device | November 4, 2021 |
| K210881 | M Series Phototherapy Equipment | June 22, 2021 |
| K182215 | ClearLink Controlled Phototherapy Equipment | October 29, 2018 |
| K153749 | 3 Series Phototherapy Unit | June 30, 2016 |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | September 10, 2015 |
| K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | October 20, 2011 |
| K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | August 29, 2011 |
| K103708 | ML24000 UVA-1 PHOTOTHERAPY UNIT | February 22, 2011 |
| K100628 | PLASMALUXLS | November 24, 2010 |
| K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 | April 28, 2010 |
| K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET | December 17, 2008 |
| K073587 | DERMAPAL WITH DIGITAL TIMER | January 18, 2008 |
| K050695 | FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT | April 19, 2005 |
| K042502 | 3 SERIES PHOTOTHERAPY CABINET | October 14, 2004 |
| K022104 | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NAR | September 10, 2002 |