The Daavlin Distributing Co.
Bryan, OH, US
THE DAAVLIN DISTRIBUTING CO. appears in FDA device records in Bryan, OH. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for The Daavlin Distributing Co. between 2002 and 2023. The busiest year on record is 2011, with 3. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 2 |
| 2010 | 2 |
| 2011 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233811 | DT Controlled Phototherapy Equipment | FTC | Substantially Equivalent | |
| K230382 | 3 Series NeoLux | FTC | Substantially Equivalent | |
| K220840 | 1 Series Phototherapy Equipment | FTC | Substantially Equivalent | |
| K212510 | 7 Series Phototherapy Device | FTC | Substantially Equivalent | |
| K210881 | M Series Phototherapy Equipment | FTC | Substantially Equivalent | |
| K182215 | ClearLink Controlled Phototherapy Equipment | FTC | Substantially Equivalent | |
| K153749 | 3 Series Phototherapy Unit | FTC | Substantially Equivalent | |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | FTC | Substantially Equivalent | |
| K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | FTC | Substantially Equivalent | |
| K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | FTC | Substantially Equivalent | |
| K103708 | ML24000 UVA-1 PHOTOTHERAPY UNIT | FTC | Substantially Equivalent | |
| K100628 | PLASMALUXLS | ONE | Substantially Equivalent | |
| K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 | FTC | Substantially Equivalent | |
| K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET | FTC | Substantially Equivalent | |
| K073587 | DERMAPAL WITH DIGITAL TIMER | FTC | Substantially Equivalent | |
| K050695 | FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT | FTC | Substantially Equivalent | |
| K042502 | 3 SERIES PHOTOTHERAPY CABINET | FTC | Substantially Equivalent | |
| K022104 | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ | FTC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1526255 | 1526255 | THE DAAVLIN DISTRIBUTING CO. | 205 W. BEMENT STREET, Bryan, OH 43506 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2744-2026 | Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). | Class II | Open, Classified | |
| Z-2743-2026 | Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). | Class II | Open, Classified | |
| Z-2742-2026 | Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). | Class II | Open, Classified | |
| Z-2295-2026 | Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4 | Some of the Calibration/Output Certificates had the outputs reversed. | Class II | Open, Classified | |
| Z-1074-2022 | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6. | Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing. | Class II | Open, Classified | |
| Z-1073-2022 | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1] | Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing. | Class II | Open, Classified | |
| Z-1237-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048. | Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. | Terminated | ||
| Z-1236-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048. | Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. | Terminated | ||
| Z-1235-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #LNBH-0048. | Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. | Terminated | ||
| Z-1234-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model All Touch Control System, Model #ASNBSM-2424 units manufactured between 6/5/03 and 4/30/04.. | Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. | Terminated | ||
| Z-1233-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Models #PASNBSM-2424. | Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain