XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD

FDA Device Registration & Listing · Xuzhou Jiangsu, CN · Registration 3008393409

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008393409
FEI Number
3008393409
Entity Name
XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD
City/State/Country
Xuzhou Jiangsu, CN
Establishment Address
Kernel Mansion, Economic Development District, Xuzhou Jiangsu 221004, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD (Owner Number: 10046889)
Owner / Operator Contact Address
Kernel Mansion, Economic Development District, Xuzhou, CN-JS 221004, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200971
PMA Number
N/A

All Registered Proprietary Names

Colposcope System KN-2200,KN-2200A,KN-2200B,KN-2200B1,KN-2200I,KN-2200I(H) KN-9000A KN-9000B KN-4001/KN-4002/KN-4003/KN-4004/ KN4005/KN4006 KN-4003AL,KN-4003B,KN-4003BL,KN-4006AL,KN-4006B,KN-4006BL UV PHOTOTHERAPY UV Phototherapy JuveLight LED Light Therapy Device iLight LED Pro 308nm Excimer Phototherapy Device CN-308E KN-4003B3 KN-4003B4 KN-5000C KN-5000D KN-5000H KN-5000K Hair Growth System Device (Model: KN-8000A) FolliLight POLY Go Hair Growth System Model: KN-8000B; KN-8000C; KN-8000D; KN-8000E, POLY Pro Regen POLY Pro ULTRA Regen PHOCUS-PRO PHOCUS-ULTRA 308nm Excimer System KN-5000C,KN-5000D ExciLight

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology Class 2 884.1630 2016-11-22
GMB Light, Wood'S, Fluorescence Microbiology Class 1 866.2600 2017-04-08
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2014-05-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-02-02
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2025-02-10
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2021-03-03
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2019-09-23
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2020-07-06
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2020-11-17
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2021-09-05

Official Correspondent

Wei Zhao

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K800950 Tanit, Inc. TANIT HOME SUNTANNING UNIT 1980-06-04
K230382 Daavlin Distributing Co. 3 Series NeoLux 2023-03-24
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008393409. Last updated year: 2026. Please use registration number 3008393409 when referencing this establishment in official correspondence.
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