Company ยท US
Daavlin Distributing Co.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2023. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
11recalls (4 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2023 | K233811 | DT Controlled Phototherapy Equipment Daavlin Distributing Co. | FTC |
| Mar 24, 2023 | K230382 | 3 Series NeoLux Daavlin Distributing Co. | FTC |
| Apr 22, 2022 | K220840 | 1 Series Phototherapy Equipment Daavlin Distributing Co. | FTC |
| Nov 4, 2021 | K212510 | 7 Series Phototherapy Device Daavlin Distributing Co. | FTC |
| Jun 22, 2021 | K210881 | M Series Phototherapy Equipment Daavlin Distributing Co. | FTC |
| Oct 29, 2018 | K182215 | ClearLink Controlled Phototherapy Equipment Daavlin Distributing Company | FTC |
| Jun 30, 2016 | K153749 | 3 Series Phototherapy Unit Daavlin Distributing Company | FTC |
| Sep 10, 2015 | K151795 | ML24000 UVA-1 Phototherapy Cabinet Daavlin Distributing Co. | FTC |
| Oct 20, 2011 | K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE Daavlin Distributing Co. | FTC |
| Aug 29, 2011 | K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES Daavlin Distributing Co. | FTC |
| Feb 22, 2011 | K103708 | ML24000 UVA-1 PHOTOTHERAPY UNIT The Daavlin Distributing Company | FTC |
| Nov 24, 2010 | K100628 | PLASMALUXLS Daavlin Distributing Co. | ONE |
| Apr 28, 2010 | K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 Daavlin Distributing Co. | FTC |
| Dec 17, 2008 | K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET Daavlin Distributing Co. | FTC |
| Jan 18, 2008 | K073587 | DERMAPAL WITH DIGITAL TIMER Daavlin Distributing Co. | FTC |
| Apr 19, 2005 | K050695 | FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT Daavlin Distributing Co. | FTC |
| Oct 14, 2004 | K042502 | 3 SERIES PHOTOTHERAPY CABINET Daavlin Distributing Co. | FTC |
| Sep 10, 2002 | K022104 | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ Daavlin Distributing Co. | FTC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2026 | Daavlin Distributing Company Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified |
FTC | K182215 |
| Jul 15, 2026 | Daavlin Distributing Company Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified |
FTC | K212510 |
| Jul 15, 2026 | Daavlin Distributing Company Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified |
FTC | K210881 |
| Jun 2, 2026 | Daavlin Distributing Company 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 physici Open, Classified |
FTC | K220840 |
| Apr 26, 2022 | Daavlin Distributing Company 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. Open, Classified |
FTC | K111172 |
| Apr 26, 2022 | Daavlin Distributing Company 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 Open, Classified |
FTC | K100378 |
| Jul 30, 2004 | Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048. Terminated |
FTC | None listed |
| Jul 30, 2004 | Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048. Terminated |
FTC | None listed |
| Jul 30, 2004 | Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #LNBH-0048. Terminated |
FTC | None listed |
| Jul 30, 2004 | Daavlin Distributing Company 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.. Terminated |
FTC | None listed |
| Jul 30, 2004 | Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Models #PASNBSM-2424. Terminated |
FTC | None listed |