Houva II Uvb
FDA 510(k) K885026 · National Biological Corp.
510(k) numberK885026
Submission
- Device name
- Houva II Uvb
- Applicant
- National Biological Corp.
Twinsburg, OH, US - Received
- December 5, 1988
- Decision date
- June 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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| 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 |
|---|---|---|
| K150912 | Houva-NET Control SystemFTC · Traditional | 07/10/2015SE |
| 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 |
Questions and answers
When was Houva II Uvb cleared by the FDA?
Houva II Uvb (K885026) received a 510(k) decision of Substantially Equivalent on June 2, 1989, 179 days after the submission was received.
What is the product code of K885026?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.