UVBioTek
Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 32 Lamps, each 72" in height. Clinic use only.
8manufacturers in China registered for this device type
12catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| APK Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shenzhen GSD Tech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
| Shenzhen Peninsula Medical Group | Shenzhen | Guangdong | Manufacturer | 4 |
| Chongqing Peninsula Medical Technology Co., Ltd. | Chongqing | Chongqing | Repacker / relabeller | 2 |
| Shanghai Sigma High-Tech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Medtek Lighting Corporation, United States |
|---|---|
| FDA product code | FTC |
| Device type | Light, Ultraviolet, Dermatological |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4630 |
| 510(k) | K111049 |
| Record published | 2017-02-09 |
| Record revised | 2018-12-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Sizes | Area/surface area 286 to 5740 Square inch; weight 40 to 550 lb |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Versa-Lite 1400 | Area/Surface Area 792 Square inch | In distribution |
| 40B | Area/Surface Area 1311 Square inch | In distribution |
| Multi Directional | Weight 235 lb | In distribution |
| 1600B | Area/Surface Area 4480 Square inch | In distribution |
| 800B | Weight 400 lb | In distribution |
| 3200B | Area/Surface Area 5740 Square inch | In distribution |
| 20B | Area/Surface Area 621 Square inch | In distribution |
| Mobile Lite | Area/Surface Area 286 Square inch | In distribution |
| 4000B | Area/Surface Area 5740 Square inch | In distribution |
| 100B | Area/Surface Area 1311 Square inch | In distribution |
| 2400B | Area/Surface Area 5740 Square inch | In distribution |
| 80B | Area/Surface Area 1311 Square inch | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Daavlin | Daavlin Distributing Co., THE | 559 |
| National Biological Corporation | National Biological Corp. | 68 |
| Kernel | Xuzhou Kernel Medical Equipment Co Ltd | 31 |
| Solarc/SolRx E-Series | Solarc Systems Inc. | 16 |
| Solarc/SolRx 100-Series | Solarc Systems Inc. | 7 |
| Solarc/SolRx 1000-Series | Solarc Systems Inc. | 7 |
| Solarc/SolRx 500-Series | Solarc Systems Inc. | 7 |
| Boston Aesthetics | Shenzhen Peninsula Medical Group | 4 |
| Panosol 6-3D | Daavlin Distributing Co., THE | 4 |
| Panosol 6 | Daavlin Distributing Co., THE | 4 |
| Panosol 6 | National Biological Corp. | 4 |
| Panosol 6-3D | National Biological Corp. | 4 |
Showing 12 of 43. All products under Light, Ultraviolet, Dermatological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K134009 | 2014-10-15 |
| K111049 | 2012-05-25 |
| K051330 | 2005-11-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.