Daavlin Distributing Co.
Medical device manufacturer in Bryan, OH.
18510(k) clearances
0PMA approvals
6recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K233811 | DT Controlled Phototherapy EquipmentFTC · Special | 12/13/2023SE |
| K230382 | 3 Series NeoLuxFTC · Special | 03/24/2023SE |
| K220840 | 1 Series Phototherapy EquipmentFTC · Special | 04/22/2022SE |
| K212510 | 7 Series Phototherapy DeviceFTC · Traditional | 11/04/2021SE |
| K210881 | M Series Phototherapy EquipmentFTC · Traditional | 06/22/2021SE |
| K182215 | ClearLink Controlled Phototherapy EquipmentFTC · Traditional | 10/29/2018SE |
| K153749 | 3 Series Phototherapy UnitFTC · Special | 06/30/2016SE |
| K151795 | ML24000 UVA-1 Phototherapy CabinetFTC · Special | 09/10/2015SE |
| K110912 | Smart Touch Uvtherapy Multiple MachineFTC · Traditional | 10/20/2011SE |
| K111172 | 4 Series Phototherapy Unit Model 4 SeriesFTC · Traditional | 08/29/2011SE |
| K103708 | ML24000 UVA-1 Phototherapy UnitFTC · Traditional | 02/22/2011SE |
| K100628 | PlasmaluxlsONE · Traditional | 11/24/2010SE |
| K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4FTC · Traditional | 04/28/2010SE |
| K082731 | ML24000 UVA-1 Phototherapy CabinetFTC · Traditional | 12/17/2008SE |
| K073587 | Dermapal with Digital TimerFTC · Traditional | 01/18/2008SE |
| K050695 | Flex Controlled Phototherapy EquipmentFTC · Traditional | 04/19/2005SE |
| K042502 | 3 Series Phototherapy CabinetFTC · Traditional | 10/14/2004SE |
| K022104 | Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,UVB Narrow Band…FTC · Traditional | 09/10/2002SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2744-2026 Class II | Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed… | 03/05/2026Open, Classified |
| Z-2743-2026 Class II | Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed… | 03/05/2026Open, Classified |
| Z-2742-2026 Class II | Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed… | 03/05/2026Open, Classified |
| Z-2295-2026 Class II | Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders…Some of the Calibration/Output Certificates had the outputs reversed. | 12/10/2025Open, Classified |
| Z-1074-2022 Class II | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software…Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment… | 04/26/2022Open, Classified |
| Z-1073-2022 Class II | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software…Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment… | 04/26/2022Open, Classified |