Xuzhou Kernel Medical Equipment Co Ltd
Manufacturer and brand owner in Xuzhou, Jiangsu, China. 7 device types, 4 products catalogued, 9 clearances.
Xuzhou Kernel Medical Equipment Co Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Laser, Comb, Hair, Light, Wood’S, Fluorescence and 5 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008393409 |
| FEI number | 3008393409 |
| DUNS | 530873660 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xuzhou |
|---|---|
| Province | Jiangsu |
| Address | Kernel Mansion |
| Postal code | 221004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | Class 2 | Colposcope System, KN-2200,KN-2200A,KN-2200B,KN-2200B1,KN-2200I,KN-2200I(H) | 2016 | 4 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | POLY Pro Regen, POLY Pro ULTRA Regen, Phocus-PRO, Phocus-Ultra | 2020 | 235 |
| Laser, Comb, Hair | Class 2 | Hair Growth System Model: KN-8000B; KN-8000C; KN-8000D; KN-8000E,, Hair Growth System Device (Model: KN-8000A), FolliLight | 2020 | 30 |
| Light, Ultraviolet, Dermatological | Class 2 | 308nm Excimer System, KN-5000C,KN-5000D, ExciLight, KN-4003AL,KN-4003B,KN-4003BL,KN-4006AL,KN-4006B,KN-4006BL, KN-4001/KN-4002/KN-4003/KN-4004/ KN4005/KN4006, UV Phototherapy and 3 more | 2014 | 8 |
| Light, Wood’S, Fluorescence | Class 1 | KN-9000B, KN-9000A | 2017 | 3 |
| Over-The-Counter Powered Light Based Laser For Acne | Class 2 | POLY Go | 2019 | 59 |
| Powered Laser Surgical Instrument | Class 2 | POLY Rejuv, POLY Clear, POLY Regen, iLight LED Pro, JuveLight, LED Light Therapy Device | 2017 | 92 |
Own-Brand Listings
Clearances
9 clearances name Xuzhou Kernel Medical Equipment Co Ltd as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261775 | 2026-07-21 | Traditional | This company | |
| K242977 | 2025-02-06 | FTC | Traditional | This company |
| K222751 | 2023-02-01 | GEX | Traditional | This company |
| K200971 | 2020-12-15 | FTC | Traditional | This company |
| K200929 | 2020-06-03 | OAP | Traditional | This company |
| K190685 | 2019-07-26 | OAP | Traditional | This company |
| K181805 | 2019-01-11 | FTC | Traditional | This company |
| K160341 | 2016-09-14 | HEX | Traditional | This company |
| K132643 | 2014-01-30 | FTC | Traditional | This company |
| K170187 | 2017-07-28 | GEX | Traditional | Uvbiotek, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1997 |
|---|---|
| Main products | UV Phototherapy systems, LED PDT devices, 308nm Excimer systems, Colposcope systems, Wood’s Lamp |
| Certifications | FDA, CE |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.