Kernel

Basic Information

• Brand Name: Kernel
• Primary DI: 06928798600421
• Version / Model: KN-5000H
• Company Name: Xuzhou Kernel Medical Equipment Co., Ltd.
• Labeler DUNS: 530873660
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-11
• Public Version: 2
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: f2b91a13-86a7-4db8-adce-05caee0b659a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	878.4630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34669	Ultraviolet phototherapy unit, home-use	An electrically-powered portable device that includes a lamp which emits light in the ultraviolet (UV) band intended to be used in the home to treat dermatological disorders (e.g., psoriasis, dermatitis) and/or to stimulate the production of endogenous vitamin D. It may have various forms (e.g., flat panel, hand-held tool, desktop unit) and is designed to shine UV light directly on the skin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06928798600421	GS1

Premarket Submissions

Submission Number	Supplement Number
K242977	000