{"product_id":"kernal-kn-4006bl1-311nm-narrowband-uvb-phototherapy-lamp-for-vitiligo","title":"Kernal  KN-4006BL1 311nm Narrowband UVB Phototherapy Lamp for Vitiligo","description":"\u003cp\u003e\u003cstrong\u003eHome-Use Narrowband UVB Phototherapy Device\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe 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.\u003c\/p\u003e\n\u003ch2\u003eIndications\u003c\/h2\u003e\n\u003cp\u003eThe KN-4006BL1 is positioned for phototherapy workflows involving:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eVitiligo\u003c\/li\u003e\n\u003cli\u003ePsoriasis\u003c\/li\u003e\n\u003cli\u003eEczema\u003c\/li\u003e\n\u003cli\u003eDermatitis\u003c\/li\u003e\n\u003cli\u003ePityriasis rosea\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eTreatment 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.\u003c\/p\u003e\n\u003ch2\u003eLight Source\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003ePhilips UV Lamp\u003c\/strong\u003e 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.\u003c\/p\u003e\n\u003ch2\u003eKey Features\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eRecognized Treatment Approach\u003c\/strong\u003e 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.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDust-Proof Design\u003c\/strong\u003e 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.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSimple, Home-Ready Operation\u003c\/strong\u003e 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.\u003c\/p\u003e\n\u003ch2\u003eCertifications\u003c\/h2\u003e\n\u003cp\u003eCE, FDA\u003c\/p\u003e\n\u003ch2\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eWhat skin conditions is the KN-4006BL1 positioned for?\u003c\/strong\u003e The device is positioned for phototherapy workflows involving vitiligo, psoriasis, eczema, dermatitis, and pityriasis rosea, as directed by the treating physician.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eIs this device suitable for home use?\u003c\/strong\u003e Yes. It's designed with simple operation specifically so patients can use it at home as part of a physician-guided treatment plan.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat light source does it use?\u003c\/strong\u003e A Philips UV lamp delivering narrowband UVB output at 311nm.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhy is narrowband UVB used for these conditions?\u003c\/strong\u003e 311nm narrowband UVB is currently recognized as one of the safest and most effective phototherapy wavelengths for treating vitiligo and psoriasis specifically.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003ch2 dir=\"ltr\"\u003eONE (1) YEAR LIMITED DEPOT WARRANTY (EU\/EEA — CE MDR Version)\u003c\/h2\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003e1. Warranty Provider and Term\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003eThis 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.\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003e2. Depot-Only Return Procedure\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003eWarranty service is strictly a depot-return process conducted directly by the manufacturer of this particular product.\u003c\/p\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003e\n\u003cstrong\u003eFirst Step (Intake):\u003c\/strong\u003e 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 \u003ca href=\"mailto:contacteurope2@medaza-platform.com\"\u003econtacteurope2@medaza-platform.com\u003c\/a\u003e.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDelegation:\u003c\/strong\u003e Upon receipt of the email, Medaza Europe, d.o.o. — acting in its capacity as \u003cstrong\u003edistributor\u003c\/strong\u003e 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.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eShipment:\u003c\/strong\u003e 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.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003e3. Allocation of Shipping Costs (Two-Way Shipping)\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003eThe 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:\u003c\/p\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003e\n\u003cstrong\u003eInbound Shipping:\u003c\/strong\u003e The cost to safely transport the product from the Buyer's facility to the designated service location of the manufacturer.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOutbound Shipping:\u003c\/strong\u003e 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.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003e4. Field Safety Corrective Action \u0026amp; Systemic Defect Exception\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003eThe 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 \u003cstrong\u003eField Safety Corrective Action (FSCA)\u003c\/strong\u003e, 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.\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003e5. Warranty Exclusions\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003eThis warranty does not cover:\u003c\/p\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003eDisposable clinical consumables (including but not limited to needles, sutures, applicators, and single-use accessories) once packaging is opened.\u003c\/li\u003e\n\u003cli\u003eDamage caused by accident, abuse, liquid spills, improper sterilization or disinfection, neglect, patient misuse, or unauthorized modifications or repairs.\u003c\/li\u003e\n\u003cli\u003eDamage resulting from use outside the manufacturer's labeled indications, intended purpose, or instructions for use (IFU), as defined under MDR Article 2.\u003c\/li\u003e\n\u003cli\u003eNormal wear and tear, consumable component degradation (e.g., lamps, filters, probes), or cosmetic degradation that does not affect device function or safety.\u003c\/li\u003e\n\u003cli\u003eAny device on which the Unique Device Identifier (UDI), serial number, or product identification label has been removed, altered, or defaced.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003e6. Incident Reporting and Vigilance\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003eNothing 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.\u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003e7. Distributor Obligations Notice\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp dir=\"ltr\"\u003eFor this product, Medaza Europe, d.o.o. acts solely as \u003cstrong\u003edistributor\u003c\/strong\u003e 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.\u003c\/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"Kernal Medical","offers":[{"title":"Default Title","offer_id":48361511911611,"sku":"KERNAL007","price":0.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0718\/9040\/3515\/files\/Screenshot2026-09-14at12.20.29PM.png?v=1789418109","url":"https:\/\/eu.medaza-platform.com\/products\/kernal-kn-4006bl1-311nm-narrowband-uvb-phototherapy-lamp-for-vitiligo","provider":"Medaza Europe ","version":"1.0","type":"link"}