Kernal KN-7000D LED Photodynamic Light Therapy Machine
Kernal KN-7000D LED Photodynamic Light Therapy Machine
KN-7000D LED Photodynamic Light Therapy Machine
Professional Multi-Color LED Light Therapy for Acne, Inflammation, and Wound Healing
The KN-7000D is a professional LED photodynamic light therapy system designed for structured, non-invasive skin treatment in clinical settings. Built around a high-power SMD matrix light source with red, blue, and yellow output, the KN-7000D is positioned for institutions running acne care, inflammation management, and post-procedure wound healing protocols.
Certification: CE MDR
Indications
The KN-7000D is positioned for:
- Inflammatory acne
- Inflammation elimination
- Promotion of skin wound healing
Treatment selection and protocol should be determined by the treating practitioner based on the patient's condition.
Light Source & Color Combination
High-Power SMD Matrix Light Source A densely arranged SMD matrix light source boosts irradiation intensity while maintaining a uniform light spot across the treatment area — designed to avoid the "hot spots" or uneven output that can come with lower-density LED arrangements.
Multi-Color Combination The treatment head supports red, blue, and yellow light, selectable as single-color or combined three-color output from one head. This allows practitioners to match the light source configuration to the specific clinical requirement, rather than switching devices between treatment types.
Key Features
Dose Working Mode with Intensity Calibration A dedicated dose mode, paired with a radiation intensity calibration system, is built in to help ensure treatment precision session to session — supporting more consistent, repeatable dosing rather than relying on fixed time settings alone.
5 Pre-Stored Treatment Plans Five pre-stored treatment plans are built in, with one-click selection designed to simplify day-to-day operation for clinical staff.
Continuous and Pulse Irradiation Modes Two working modes — continuous and pulse irradiation — give practitioners more flexibility to match treatment delivery to different clinical needs.
Adjustable, Extendable Treatment Head The treatment head is adjustable to accommodate various treatment areas. An aerodynamic design combined with high-grade thermal materials is intended to keep the head stable and safe to operate, even during extended clinical use.
Cantilever Positioning A cantilever design allows the light panel to be fixed at any desired angle or position, supporting easier positioning across different treatment areas and patient setups.
8" Full Touch Screen An 8-inch full touch screen with a user-friendly GUI is designed to make operation more concise and smooth for clinical staff.
Patient Comfort Features A warm voice reminder function is included to support a more relaxed, comfortable treatment experience for patients during sessions.
Dual-Layer Access Protection A key switch combined with a power-on password provides two layers of protection against unauthorized or unrelated use of the device.
Non-Invasive, High-Purity Light Source The system uses a high-purity light source for non-invasive treatment, with no special aftercare required following a session.
Technical Overview
| Spec | Detail |
|---|---|
| Light source | High-power SMD matrix LED |
| Color options | Red, Blue, Yellow (single or 3-color combination) |
| Working modes | Continuous / Pulse |
| Treatment plans | 5 pre-stored plans |
| Display | 8" full touch screen |
| Access control | Key switch + power-on password |
| Certifications | ISO13485, CFDA, CE |
Who It's For
- Dermatology clinics
- Medical aesthetics practices
- Skin treatment centers
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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