Kernel
The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
8manufacturers in China registered for this device type
31catalogue numbers in this listing
4510(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 | Xuzhou Kernel Medical Equipment Co Ltd, China |
|---|---|
| FDA product code | FTC |
| Device type | Light, Ultraviolet, Dermatological |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4630 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K181805 |
| Record published | 2019-03-08 |
| Record revised | 2025-10-09 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 8, pack of 12, pack of 10, pack of 4, pack of 6, pack of 5 |
| Distribution end date | 2021-01-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KN-4003AL2S | In distribution | |
| KN-4003AL2 | In distribution | |
| KN-4003BL | In distribution | |
| KN-5000D | In distribution | |
| KN-5000K | In distribution | |
| KN-4006BL1S | In distribution | |
| KN-4006B | In distribution | |
| KN-4003B | In distribution | |
| KN-4003AL | In distribution | |
| KN-4006AL1D | In distribution | |
| CN-308E | In distribution | |
| KN-5000C | In distribution | |
| KN-4006AL1DS | In distribution | |
| KN-4003AL2D | In distribution | |
| KN-4006AL1S | In distribution | |
| KN-4006BL1D | In distribution | |
| KN-4003BL2 | In distribution | |
| KN-4003AL2DS | In distribution | |
| KN-4006AL | In distribution | |
| KN-4003B4 | In distribution | |
| KN-4006AL1 | In distribution | |
| KN-4003BL2S | In distribution | |
| KN-4006BL1DS | In distribution | |
| KN-4006BL | In distribution | |
| KN-4003BL2D | In distribution | |
| KN-4006BL1 | In distribution | |
| KN-4003B3 | In distribution | |
| KN-5000H | In distribution | |
| KN-4003BL2DS | In distribution | |
| KN-5000C | Withdrawn | |
| KN-5000D | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Daavlin | Daavlin Distributing Co., THE | 559 |
| National Biological Corporation | National Biological Corp. | 68 |
| Solarc/SolRx E-Series | Solarc Systems Inc. | 16 |
| UVBioTek | Medtek Lighting Corporation | 12 |
| 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 |
|---|---|
| K242977 | 2025-02-06 |
| K200971 | 2020-12-15 |
| K181805 | 2019-01-11 |
| K132643 | 2014-01-30 |
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.