Data / Medical devices / United States / The Daavlin Distributing Co.
The Daavlin Distributing Co.: FDA-registered device maker in Bryan, OH, United States, 25 510(k) clearances
The Daavlin Distributing Co. is registered with the FDA (registration 1526255) in Bryan, OH, United States. It lists 2 device types. The FDA files 25 510(k) clearances under its listings, the newest dated December 13, 2023. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1526255
- Address
- 205 W. Bement Street, Bryan, OH, United States, 43506
- Owner or operator
- THE DAAVLIN DISTRIBUTING CO. (1526255)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 31, 2007
- Registered through
- 2026
- Brand names listed
- 1 SERIES, 1 Series CX, 2 SERIES, 3 SERIES, 3 SERIES SP/PC, 3 SERIES X, 3 Series NeoLux CX, 3 Series Neolux and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument | ONE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2023 | K233811 | DT Controlled Phototherapy Equipment | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| March 24, 2023 | K230382 | 3 Series NeoLux | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| April 22, 2022 | K220840 | 1 Series Phototherapy Equipment | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| November 4, 2021 | K212510 | 7 Series Phototherapy Device | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| June 22, 2021 | K210881 | M Series Phototherapy Equipment | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| October 29, 2018 | K182215 | ClearLink Controlled Phototherapy Equipment | FTC | Substantially Equivalent | Daavlin Distributing Company | accessdata.fda.gov |
| June 30, 2016 | K153749 | 3 Series Phototherapy Unit | FTC | Substantially Equivalent | Daavlin Distributing Company | accessdata.fda.gov |
| September 10, 2015 | K151795 | ML24000 UVA-1 Phototherapy Cabinet | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| October 20, 2011 | K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| August 29, 2011 | K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| February 22, 2011 | K103708 | ML24000 UVA-1 PHOTOTHERAPY UNIT | FTC | Substantially Equivalent | The Daavlin Distributing Company | accessdata.fda.gov |
| November 24, 2010 | K100628 | PLASMALUXLS | ONE | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| April 28, 2010 | K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| November 5, 2009 | K091568 | LH-75 PHOTOTHERAPY SYSTEM | FTC | Substantially Equivalent | Lerner Medical Devices, Inc. | accessdata.fda.gov |
| February 26, 2009 | K090097 | LH-75T PHOTOTHERAPY SYSTEM | FTC | Substantially Equivalent | Lerner Medical Devices, Inc. | accessdata.fda.gov |
| December 17, 2008 | K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| January 18, 2008 | K073587 | DERMAPAL WITH DIGITAL TIMER | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| January 17, 2007 | K063621 | 3 SERIES PHOTOTHERAPY CABINET | FTC | Substantially Equivalent | Daavlin Co. | accessdata.fda.gov |
| April 19, 2005 | K050695 | FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| October 14, 2004 | K042502 | 3 SERIES PHOTOTHERAPY CABINET | FTC | Substantially Equivalent | Daavlin Distributing Co. | accessdata.fda.gov |
| June 9, 2004 | K041212 | HOUVA 3 PHOTOTHERAPY SYSTEM | FTC | Substantially Equivalent | National Biological Corp. | accessdata.fda.gov |
| February 13, 2004 | K040062 | LEVIA PHOTOTHERAPY SYSTEM | FTC | Substantially Equivalent | Lerner Medical Devices, Inc. | accessdata.fda.gov |
| September 10, 2002 | 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 | Daavlin Distributing Co. | accessdata.fda.gov |
| November 20, 1992 | K924077 | HANDISOL | FTC | Substantially Equivalent | National Biological Corp. | accessdata.fda.gov |
| November 25, 1985 | K854498 | SPECTRA 724 | FTC | Substantially Equivalent | Daavlin Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 5, 2026 | 99331 | Class II | Ongoing | 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). | accessdata.fda.gov |
| December 10, 2025 | 98817 | Class II | Ongoing | 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 21 | Some of the Calibration/Output Certificates had the outputs reversed. | accessdata.fda.gov |
| April 26, 2022 | 89990 | Class II | Ongoing | 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 | 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. | accessdata.fda.gov |
| September 1, 2003 | 29387 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Ultraviolet, Dermatological
- All makers of Powered Light Based Non-Laser Surgical Instrument
Updated July 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.