4 Series Phototherapy Unit Model 4 Series
FDA 510(k) K111172 · Daavlin Distributing Co.
510(k) numberK111172
Submission
- Device name
- 4 Series Phototherapy Unit Model 4 Series
- Applicant
- Daavlin Distributing Co.
Bryan, OH, US - Received
- April 26, 2011
- Decision date
- August 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO)FTC · Traditional | Choyang Medics Co., Ltd. | 05/01/2026SE |
| K253871 | Klär Lite (RCW-KL1000)FTC · Traditional | Radcliffe Watts, LLC | 03/04/2026SE |
| K250425 | Ultraviolet Phototherapy DeviceFTC · Traditional | APK Technology Co., Ltd. | 04/07/2025SE |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…FTC · Traditional | Boston Aesthetics, Inc. | 03/13/2025SE |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 02/06/2025SE |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD…FTC · Traditional | Shanghai Sigma High-Tech Co., Ltd. | 12/19/2024SE |
| K233811 | DT Controlled Phototherapy EquipmentFTC · Special | Daavlin Distributing Co. | 12/13/2023SE |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)FTC · Traditional | Shenzhen Honpal Optoelectronic Technology Co.… | 03/27/2023SE |
| K230382 | 3 Series NeoLuxFTC · Special | Daavlin Distributing Co. | 03/24/2023SE |
| K230076 | Enhanced AURORA Medical Diode System, and related accessoriesFTC · Traditional | Psoria-Shield, Inc. | 03/08/2023SE |
More from Psoria-Shield, Inc.
| 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 |
| K103708 | ML24000 UVA-1 Phototherapy UnitFTC · Traditional | 02/22/2011SE |
Questions and answers
When was 4 Series Phototherapy Unit Model 4 Series cleared by the FDA?
4 Series Phototherapy Unit Model 4 Series (K111172) received a 510(k) decision of Substantially Equivalent on August 29, 2011, 125 days after the submission was received.
What is the product code of K111172?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.