Houva-NET Control System
FDA 510(k) K150912 · National Biological Corporation
510(k) numberK150912
Submission
- Device name
- Houva-NET Control System
- Applicant
- National Biological Corporation
Beachwood, OH, US - Received
- April 3, 2015
- Decision date
- July 10, 2015
- 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 |
|---|---|---|
| K070934 | Panosol II Tru-Blu, Model UBL-417FTC · Traditional | 05/22/2007SE |
| K041212 | Houva 3 Phototherapy SystemFTC · Special | 06/09/2004SE |
| K982082 | Handisol Wound HealingFTC · Traditional | 10/28/1998SE |
| K934808 | Uvisol and Uvisol IIFTC · Traditional | 12/16/1993SE |
| K924969 | Phototherapy TimerFTC · Traditional | 02/23/1993SE |
| K924077 | HandisolFTC · Traditional | 11/20/1992SE |
| K904428 | Panosol II UAB-228FTC · Traditional | 12/24/1990SE |
| K904427 | Panosol II UVB-206FTC · Traditional | 12/24/1990SE |
| K904426 | Panosol II UVA-218FTC · Traditional | 12/24/1990SE |
| K885029 | Houva II Uva/UvbFTC · Traditional | 06/02/1989SE |
Questions and answers
When was Houva-NET Control System cleared by the FDA?
Houva-NET Control System (K150912) received a 510(k) decision of Substantially Equivalent on July 10, 2015, 98 days after the submission was received.
What is the product code of K150912?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.