Ultraviolet Phototherapy Device
FDA 510(k) K250425 · APK Technology Co., Ltd.
510(k) numberK250425
Submission
- Device name
- Ultraviolet Phototherapy Device
- Applicant
- APK Technology Co., Ltd.
Shenzhen, CN - Received
- February 14, 2025
- Decision date
- April 7, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K220840 | 1 Series Phototherapy EquipmentFTC · Special | Daavlin Distributing Co. | 04/22/2022SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 SensorsDQA · Traditional | 06/08/2018SE |
| K170536 | ECG Disposable Lead WireDSA · Traditional | 04/24/2017SE |
| K102825 | Blood Pressure CuffDXQ · Traditional | 03/02/2011SE |
| K082846 | Apk SPO2 Pulse Oximeter SensorDQA · Traditional | 04/03/2009SE |
| K903963 | Kits and Trays for One Time Use OnlyLRP · Traditional | 07/29/1991SEKD |
| K903962 | Instruments for One Time Use/ DisposableLRP · Traditional | 07/29/1991SEKD |
Questions and answers
When was Ultraviolet Phototherapy Device cleared by the FDA?
Ultraviolet Phototherapy Device (K250425) received a 510(k) decision of Substantially Equivalent on April 7, 2025, 52 days after the submission was received.
What is the product code of K250425?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.