Kernal KN-5000D 308nm Excimer Laser System — Targeted Dermatology Treatment for Vitiligo
Kernal KN-5000D 308nm Excimer Laser System — Targeted Dermatology Treatment for Vitiligo
Compact, High-Precision 308nm Excimer Phototherapy for Clinical and Home Settings
The KN-5000D is a compact 308nm excimer laser phototherapy system built around imported xenon chloride (XeCl) excimer light source technology. Designed with a smaller footprint and lower consumable cost than larger excimer platforms, it delivers high-intensity, precisely targeted treatment suitable for both clinical dermatology settings and stationary home use.
Certification: FDA 510K cleared, CE MDR
Indications
The KN-5000D is positioned for phototherapy workflows involving:
- Vitiligo
- Psoriasis
- Eczema
- Pityriasis rosea
Treatment protocols and suitability should be determined by the treating physician based on lesion size, location, and patient condition.
Light Source
XeCl Excimer Light — 308nm The system uses the latest generation of imported xenon chloride gas light source, continuously emitting high-intensity single-frequency 308nm excimer light with a stable waveband and pure spot — supporting effective, targeted treatment with fewer sessions than lower-intensity phototherapy approaches.
Key Features
Compact, Cost-Efficient Design A smaller footprint and lower consumable cost make the KN-5000D a more accessible entry point into excimer phototherapy, without sacrificing output intensity.
Quick Start, Simple Operation The system is designed for quick startup and straightforward day-to-day operation, minimizing setup time between patients or sessions.
High-Precision Targeting Good targeting accuracy allows the system to treat lesions with minimal impact on surrounding healthy skin, including lesions in areas traditional light-based devices have difficulty reaching effectively.
Six Multi-Spec Shading Sheets Six different sizes of shading sheets are included, allowing precise control over the irradiation range so treatment can be matched to different lesion sizes.
Automatic MED (Minimal Erythema Dose) Testing A built-in UV dosage scheme enables automatic six-spot skin phototoxicity testing, simplifying dose calibration into an easy, patient-specific process rather than a manual, time-consuming one.
Dual Treatment Modes Both dose mode and time mode are available, giving practitioners flexibility to select the treatment approach that best fits the protocol.
8" Touch Screen with GUI An 8-inch touch screen paired with a user-friendly GUI is designed to make operation easier and safer to monitor throughout a session.
Fingerprint Management System A fingerprint-based management system allows treatment records for different users or patients to be collected and retrieved quickly — useful for multi-patient clinical settings as well as tracking an individual's home treatment history.
Irradiation Intensity Calibration A built-in calibration system helps ensure accurate, consistent treatment dosage is maintained over time.
Optional Mobile Trolley An optional flexible trolley is available, making the device easier to move within a dermatology clinic or hospital setting to meet different workflow needs.
Technical Specifications
| Spec | Detail |
|---|---|
| Light source | 308nm excimer light (XeCl) |
| Spot size | 20cm² ± 10% |
| Irradiation intensity | 50 mW/cm² ± 10% |
| Light source lifespan | ≥500 hours |
| Weight | 12kg (gross weight) |
| Power supply | AC100–240V, 50/60Hz |
| Display | 8" touch screen |
| Certifications | CE, FDA, ISO13485, CFDA |
Who It's For
- Dermatology clinics
- Hospital dermatology departments
- Specialty phototherapy centers
- Stationary home-use settings, under physician guidance
Frequently Asked Questions
What makes the KN-5000D different from the KN-5000C? Both use the same 308nm XeCl excimer light source and 50 mW/cm² intensity. The KN-5000D is positioned as a more compact, lower-consumable-cost platform with fingerprint-based patient management, suitable for both clinical and stationary home use, while the KN-5000C is built around a flexible handheld treatment head with quick-connect light source replacement for higher-throughput clinical settings.
Is this device suitable for home use? Yes — the KN-5000D's stationary design is described as suitable for both clinical and home use, under a physician-directed treatment plan.
What is the fingerprint management system used for? It allows treatment records for multiple users or patients to be collected and retrieved quickly, supporting recordkeeping in both multi-patient clinical settings and individual home tracking.
How does MED testing work on this device? The system automates a six-spot phototoxicity test to determine the correct UV dose for the patient's specific skin characteristics, simplifying what would otherwise be a complex manual process.
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.
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