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Sign in to claim this brandNational Biological Corp.
US
Last updated May 23, 2026
What National Biological Corp. makes
National Biological Corp. manufactures ultraviolet phototherapy units designed for both home and professional medical use. These devices are intended for therapeutic applications, including the treatment of skin conditions such as psoriasis and vitiligo.
The company’s ultraviolet phototherapy units are classified as Class II devices under US regulations. They are listed in the FDA’s 510(k) and UDI registries, reflecting their authorised status for commercial distribution in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does National Biological Corp. manufacture?
National Biological Corp. specializes in ultraviolet phototherapy units, which are designed for therapeutic treatments. These devices come in two primary forms: home-use units for patient self-administration and professional units intended for clinical settings. They are specifically developed to address skin conditions like psoriasis and vitiligo through controlled ultraviolet light exposure.
Where is National Biological Corp. based, and what does that mean for its regulatory oversight?
National Biological Corp. is based in the United States. Since it operates within the US market, its devices are subject to regulatory oversight by the FDA. The company’s ultraviolet phototherapy units are classified as Class II devices, which means they undergo a premarket notification (510(k)) process to demonstrate substantial equivalence to a legally marketed predicate device before being authorised for commercial distribution.
Which regulatory registries list National Biological Corp.’s ultraviolet phototherapy units?
National Biological Corp.’s ultraviolet phototherapy units are included in the FDA’s 510(k) registry, which tracks devices that have undergone the premarket notification process. Additionally, they appear in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and identification of the devices in commercial distribution. These listings reflect their authorised status for use in the US market.
How are National Biological Corp.’s ultraviolet phototherapy units classified under US regulations?
National Biological Corp.’s ultraviolet phototherapy units are classified as Class II devices under the US regulatory framework. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness. The 510(k) process is used to demonstrate that these devices meet those controls and are substantially equivalent to a previously authorised predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (113)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Phototherapy Timer | K924969 | FDA 510(k) | Class II | Active |
| Panosol Ii Tru-Blu, Model Ubl-417 | K070934 | FDA 510(k) | Class II | Active |
| Panosol 2000 624-404 | K872707 | FDA 510(k) | Class II | Active |
| Houva-Lite Arm Unit #601 | K761186 | FDA 510(k) | Class II | Active |
| Hand/Foot Uva 624-218 | K872605 | FDA 510(k) | Class II | Active |
| Panosol 2000 624-604 | K872650 | FDA 510(k) | Class II | Active |
| Houva-Bed | K882722 | FDA 510(k) | Class II | Active |
| Foldalite Unit | K827890 | FDA 510(k) | Class II | Active |
| Handisol | K924077 | FDA 510(k) | Class II | Active |
| Panosol Ii Uab-228 | K904428 | FDA 510(k) | Class II | Active |
| Houva 3 Phototherapy System | K041212 | FDA 510(k) | Class II | Active |
| Panosol 2000 624-414 | K872651 | FDA 510(k) | Class II | Active |
| Handisol Wound Healing | K982082 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
National Biological Corp. has four FDA recall records, all initiated between February 19, 2008, and January 27, 2017, with all records marked as terminated. The recalls involved issues such as software allowing operator overrides of error warnings, potential unintended lamp activation due to wiring, and incorrect manuals being packaged with devices—specifically UVB-083 and UVB-080 units mistakenly including manuals for UVA-080 and UVA-083, respectively.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 27, 2017 | Z-1683-2017 | — | terminated | The wiring may allow the lamps to turn on with the key switch rather than the timer. |
| Apr 9, 2013 | Z-1778-2013 | — | terminated | The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. |
| Apr 8, 2013 | Z-1779-2013 | — | terminated | The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device. |
| Feb 19, 2008 | Z-1309-2008 | — | terminated | Software allows operator to override "low line voltage" error warning and store light intensity value. |