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Kernel

FDA UDI

Class II (US FDA UDI)

by Xuzhou Kernel Medical Equipment Co., Ltd.

Identity

Trade Name
Kernel FDA UDI
Generic Name
Cosmetic red-light phototherapy system, professional FDA UDI
Model / Reference
KN-7000L FDA UDI

Identifiers

Primary DI / UDI-DI
06928798600513 FDA UDI
510(k) Number
K222751 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Cosmetic red-light phototherapy system, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cosmetic red-light phototherapy system, professional

Kernel by Xuzhou Kernel Medical Equipment Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cosmetic red-light phototherapy system, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xuzhou Kernel Medical Equipment Co., Ltd.

Sources (1)

  • FDA UDI c6dbfa8d-7654-4bf0-948a-98b6e33d8465 33 fields · synced May 30, 2026