Kernal KN-4006BL1 311nm Narrowband UVB Phototherapy Lamp for Vitiligo

Home-Use Narrowband UVB Phototherapy Device

The KN-4006BL1 is a compact narrowband UVB phototherapy device built around a Philips UV lamp light source. Narrowband UVB at 311nm is widely regarded as one of the safest and most effective phototherapy approaches for vitiligo and psoriasis, and the KN-4006BL1 is designed to bring that treatment modality into a simple, home-use format.

Indications

The KN-4006BL1 is positioned for phototherapy workflows involving:

• Vitiligo
• Psoriasis
• Eczema
• Dermatitis
• Pityriasis rosea

Treatment protocols and suitability should be determined by the treating physician. This device is intended for use as directed by a healthcare provider, including for at-home maintenance phototherapy where clinically appropriate.

Light Source

Philips UV Lamp The device uses a Philips-manufactured UV lamp as its light source, selected for stability and long operating lifespan, providing consistent narrowband UVB output at 311nm across repeated home treatment sessions.

Key Features

Recognized Treatment Approach Narrowband UVB phototherapy is currently recognized as one of the safest and most effective approaches for treating vitiligo and psoriasis, making the KN-4006BL1's format well suited to supporting an established, physician-guided treatment plan.

Dust-Proof Design A dust-proof construction is built in to help keep the light source and treatment area protected between uses, supporting safer, more hygienic operation over the device's lifespan.

Simple, Home-Ready Operation The device is designed for straightforward operation, allowing patients to carry out physician-directed treatment sessions at home rather than requiring a clinic visit for each session — adding convenience for patients managing an ongoing treatment plan.

Certifications

CE, FDA

Frequently Asked Questions

What skin conditions is the KN-4006BL1 positioned for? The device is positioned for phototherapy workflows involving vitiligo, psoriasis, eczema, dermatitis, and pityriasis rosea, as directed by the treating physician.

Is this device suitable for home use? Yes. It's designed with simple operation specifically so patients can use it at home as part of a physician-guided treatment plan.

What light source does it use? A Philips UV lamp delivering narrowband UVB output at 311nm.

Why is narrowband UVB used for these conditions? 311nm narrowband UVB is currently recognized as one of the safest and most effective phototherapy wavelengths for treating vitiligo and psoriasis specifically.

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.