UV Phototherapy
FDA 510(k) K132643 · Xuzhou Kernel Medical Equipment Co., Ltd.
510(k) numberK132643
Submission
- Device name
- UV Phototherapy
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd.
Shanghai, CN - Received
- August 26, 2013
- Decision date
- January 30, 2014
- 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 |
|---|---|---|
| K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) · Traditional | 07/21/2026SE |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | 02/06/2025SE |
| K222751 | LED Light Therapy Device, KN-7000LGEX · Traditional | 02/01/2023SE |
| K200971 | 308nm Excimer SystemFTC · Traditional | 12/15/2020SE |
| K200929 | Hair Growth SystemOAP · Traditional | 06/03/2020SE |
| K190685 | Hair Growth SystemOAP · Traditional | 07/26/2019SE |
| K181805 | UV PhototherapyFTC · Traditional | 01/11/2019SE |
| K160341 | Colposcope SystemHEX · Traditional | 09/14/2016SE |
Questions and answers
When was UV Phototherapy cleared by the FDA?
UV Phototherapy (K132643) received a 510(k) decision of Substantially Equivalent on January 30, 2014, 157 days after the submission was received.
What is the product code of K132643?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.