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

Kernel KN-4003BL2 Handheld 311nm Narrowband UVB Phototherapy Device

Compact narrowband UVB phototherapy for physician-directed treatment in the clinic or at home

Available to dermatology practices and licensed healthcare providers, including for prescribing to patients for physician-directed home treatment.

The KN-4003BL2 is a handheld narrowband UVB phototherapy device built around a Philips 311nm UV lamp. It is designed for targeted treatment of localized areas where a compact device is more practical than a full-body cabinet.

Indications for Use
The KN-4003BL2 is intended for use by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I–VI). It may be used in hospitals, clinics, and households.

Rx only. Treatment protocols, dosing, and patient suitability are determined by the prescribing physician.

Regulatory Status: FDA 510(k) cleared, K181805 (Class II, product code FTC). CE marked under EU MDR.

Light Source
Philips 311nm NB-UVB Lamp: The device uses a medical ultraviolet lamp manufactured by Philips, chosen for stable output and long service life. Narrowband UVB output is centered at 311nm.

Key Features

Compact and Portable: The handheld design needs no fixed installation. It suits treatment of localized areas and patients using the device at home as prescribed.

Simple Operation: Straightforward controls make it easy to use for clinic staff and for patients following a physician's instructions.

Dustproof Design: The housing is designed to limit dust getting into the device.

Treatment Records: Supports basic record keeping so practitioners can set up and look up patient treatment information.

Microcomputer Timer: The built-in timer counts down the remaining treatment time and alerts the user, keeping sessions consistent without manual timing. Treatment time is adjustable from 0 to 30 minutes.

Comb Attachment: An integrated comb-style head lets the light reach skin under hair, which makes it useful for the scalp and other hair-covered areas.

Technical Specifications

Frequently Asked Questions

What is the KN-4003BL2 cleared to treat?
Psoriasis, vitiligo, and atopic dermatitis (eczema), on all skin types (I–VI). It is used by or under the direction of a physician.

Can patients use it at home?
Yes, when prescribed. The device is cleared for use in households as well as hospitals and clinics, under a physician's direction.

How is it different from the KN-4001 cabinet?
The KN-4003BL2 is a handheld device for targeted treatment of smaller areas. The KN-4001 is a cabinet system for whole-body sessions.

What is the comb attachment for?
The comb head parts the hair so the light reaches the skin underneath. This is useful for the scalp and other hair-covered areas.

How is treatment time controlled?
A built-in microcomputer timer counts down the remaining time and alerts the user. Sessions are adjustable from 0 to 30 minutes.

Who can purchase this device?
The KN-4003BL2 is a prescription device, sold to licensed healthcare practitioners and institutions.

ONE (1) YEAR LIMITED DEPOT WARRANTY 

1. Warranty Provider and Term

This warranty is provided and administered strictly by the manufacturer of this particular product, not by Medaza, Inc. The manufacturer warrants to the original purchasing entity ("Buyer") — including hospitals, clinics, and other licensed medical institutions within the United States — 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 rights the Buyer may hold under applicable state or federal 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, Inc. by email at contactusa@medaza-platform.com.
• Delegation: Upon receipt of the email, Medaza, Inc. — acting in its capacity as distributor — will delegate and coordinate the direct connection between the manufacturer (or the manufacturer's designated U.S. Initial Importer, where applicable) 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 the Health Insurance Portability and Accountability Act (HIPAA) and other applicable privacy laws 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 United States.

4. Recall & 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 designated U.S. Initial Importer, Medaza, Inc., or the FDA to be subject to a Recall, Safety Alert, or a verified batch-wide Systemic Manufacturing Defect, in accordance with 21 CFR Part 806 (Medical Device Reporting: Corrections and Removals) and related FDA recall procedures. 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 use, or instructions for use (IFU).
• 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 serial number, UDI (Unique Device Identifier), or product identification label has been removed, altered, or defaced.

6. Adverse Event Reporting

Nothing in this warranty limits or replaces the Buyer's independent obligation, as a healthcare institution or professional user, to report device malfunctions, serious injuries, or adverse events involving this product to the manufacturer, to the manufacturer's designated U.S. Initial Importer (where applicable), to Medaza, Inc. as distributor, and, where required under 21 CFR Part 803 (Medical Device Reporting), to the FDA (e.g., via MedWatch). Medaza, Inc. will cooperate with the manufacturer, the Initial Importer, and the FDA on any resulting investigation, corrective action, or reporting obligation.

7. Distributor Obligations Notice

For this product, Medaza, Inc. acts solely as a distributor; a separate entity — not Medaza, Inc. — handles importation and fulfills any applicable U.S. Initial Importer obligations under FDA regulations for this manufacturer's products. As distributor, Medaza, Inc. confirms it verifies that the device bears the required labeling and UDI, that it is accompanied by the manufacturer's required documentation, and that appropriate storage and transport conditions are maintained while the product is under its responsibility. This warranty does not alter or diminish those regulatory obligations, nor does it impose importer obligations on Medaza, Inc.