Kernel KN-4003BL2 311nm Narrowband UVB Lamp for Vitiligo

Compact, Portable Narrowband UVB Phototherapy Device

The KN-4003BL2 is a handheld narrowband UVB phototherapy device built around a Philips-manufactured 311nm UV lamp. Designed for portability and ease of use, it is positioned for targeted phototherapy applications where a compact, easy-to-operate device is preferable to a full cabinet system.

Certification: FDA 510K cleared, CE MDR

Indications

The KN-4003BL2 is positioned for phototherapy workflows involving:

• Vitiligo
• Psoriasis
• Eczema
• Pityriasis rosea

Treatment protocols and suitability should be determined by the treating physician based on the specific condition and patient.

Light Source

Philips 311nm NB-UVB Lamp
The device uses a special ultraviolet lamp manufactured by Philips as its treatment light source, selected for high stability and long operating life. The narrowband UVB output is centered at 311nm.

Key Features

Compact and Portable
Small in size and easy to carry, the KN-4003BL2 is built for use in settings where portability matters — including travel or business trip use — rather than requiring a fixed cabinet installation.

Simple, Accessible Operation
Straightforward controls are designed for ease of use.

Dustproof Construction
A dustproof design is built in to support safer, more hygienic treatment sessions.

Treatment Record Management
The device supports basic medical record management functionality, helping practitioners quickly establish and look up patient treatment information.

Microcomputer Timer Function
A built-in microcomputer timing function tracks and reminds the user of remaining treatment time, removing the need for manual time calculation and helping keep sessions consistent.

Unique Comb Design
A distinctive comb-style applicator head is built into the device, designed to make treatment application more flexible and convenient — particularly useful for scalp or hair-covered areas.

Technical Specifications

Frequently Asked Questions

What skin conditions is the KN-4003BL2 positioned for?
The device is positioned for phototherapy workflows involving vitiligo, psoriasis, eczema, and pityriasis rosea, as directed by the treating physician.

What makes this different from the KN-4001 cabinet system?
The KN-4003BL2 is a compact, portable handheld device suited to targeted or smaller-area treatment, while the KN-4001 is a full cabinet system built for whole-body phototherapy sessions.

What is the comb design used for?
The comb-style applicator head is designed for more flexible, direct contact application — useful for treating areas like the scalp.

How is treatment time tracked?
A built-in microcomputer timer tracks remaining treatment time and provides reminders during the session.

ONE (1) YEAR LIMITED DEPOT WARRANTY (EU/EEA — CE MDR Version)

1. Warranty Provider and Term

This warranty is provided and administered strictly by the manufacturer of this particular product, not by Medaza Europe, d.o.o. The manufacturer warrants to the original purchasing entity ("Buyer") — including hospitals, clinics, and other licensed medical institutions within the European Union / European Economic Area — that the hardware product sold shall be free from defects in materials and workmanship under normal clinical use for a period of one (1) year from the date of shipment. This warranty is provided in addition to, and does not affect, any statutory rights the Buyer may hold as a matter of applicable EU or national consumer or commercial law.

2. Depot-Only Return Procedure

Warranty service is strictly a depot-return process conducted directly by the manufacturer of this particular product.

• First Step (Intake): To initiate a warranty claim, the Buyer must not contact the manufacturer directly. The Buyer must first contact Medaza Europe, d.o.o. by email at contacteurope2@medaza-platform.com.
• Delegation: Upon receipt of the email, Medaza Europe, d.o.o. — acting in its capacity as distributor under Regulation (EU) 2017/745 (the Medical Device Regulation, "MDR") — will delegate and coordinate the direct connection between the manufacturer (or the manufacturer's designated EU importer of record) and the Buyer, facilitating return logistics and securing the required Return Merchandise Authorization (RMA) number.
• Shipment: No shipments will be accepted by the manufacturer's facility without an active, authorized RMA number. The product must be securely packaged in its original packaging (or equivalent protective packaging), with all patient-identifying information removed or de-identified in accordance with Regulation (EU) 2016/679 (the General Data Protection Regulation, "GDPR") and applicable national data protection requirements prior to shipment, and shipped directly to the designated service facility of the manufacturer.

3. Allocation of Shipping Costs (Two-Way Shipping)

The Buyer assumes full financial responsibility for all shipping logistics, packaging, handling fees, customs/tariffs, and insurance transit costs associated with the warranty claim. This includes:

• Inbound Shipping: The cost to safely transport the product from the Buyer's facility to the designated service location of the manufacturer.
• Outbound Shipping: The cost to return the repaired or replaced product from the manufacturer's facility back to the Buyer's designated location within the EU/EEA.

4. Field Safety Corrective Action & Systemic Defect Exception

The shipping cost allocation in Section 3 shall be waived solely in the event that the returned product is officially determined by the manufacturer, its EU importer of record, Medaza Europe, d.o.o., or an authorized regulatory body (e.g., a national Competent Authority such as JAZMP, or another EU/EEA Competent Authority) to be subject to a Field Safety Corrective Action (FSCA), Field Safety Notice, or a verified batch-wide Systemic Manufacturing Defect, in accordance with the vigilance and market surveillance requirements of MDR Articles 87–92. In such extraordinary circumstances, the manufacturer will cover standard two-way ground shipping costs.

5. Warranty Exclusions

This warranty does not cover:

• Disposable clinical consumables (including but not limited to needles, sutures, applicators, and single-use accessories) once packaging is opened.
• Damage caused by accident, abuse, liquid spills, improper sterilization or disinfection, neglect, patient misuse, or unauthorized modifications or repairs.
• Damage resulting from use outside the manufacturer's labeled indications, intended purpose, or instructions for use (IFU), as defined under MDR Article 2.
• Normal wear and tear, consumable component degradation (e.g., lamps, filters, probes), or cosmetic degradation that does not affect device function or safety.
• Any device on which the Unique Device Identifier (UDI), serial number, or product identification label has been removed, altered, or defaced.

6. Incident Reporting and Vigilance

Nothing in this warranty limits or replaces the Buyer's independent obligation, as a healthcare institution or professional user, to report serious incidents or field safety issues involving this product in accordance with MDR Article 87. Reports should be directed to the manufacturer, to the manufacturer's designated EU importer of record, to Medaza Europe, d.o.o. as distributor, and, where required, to the relevant national Competent Authority (e.g., JAZMP) and/or logged via EUDAMED once the relevant EUDAMED modules become mandatory. Medaza Europe, d.o.o. will cooperate with the manufacturer, the importer of record, and Competent Authorities on any resulting vigilance investigation, corrective action, or reporting obligation.

7. Distributor Obligations Notice

For this product, Medaza Europe, d.o.o. acts solely as distributor under MDR Article 14; a separate, designated importer of record — not Medaza Europe, d.o.o. — fulfills the importer obligations under MDR Article 13 for this manufacturer's products. As distributor, Medaza Europe, d.o.o. confirms it verifies that the device bears the required CE marking and UDI, that it is accompanied by the manufacturer's required documentation and, where applicable, the importer's required labeling, and that appropriate storage and transport conditions are maintained while the product is under its responsibility. This warranty does not alter or diminish those statutory obligations, nor does it impose importer obligations on Medaza Europe, d.o.o.