308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C, KN-5000D, KN-5000H, KN-5000K)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242977 FDA 510(k)
- FDA Product Code
- FTC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4630 FDA 510(k)
- Regulation Number
- 878.4630 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 308nm Excimer Phototherapy Device is a dermatological ultraviolet light source designed for targeted phototherapy. It emits narrowband ultraviolet B (UVB) radiation at 308 nanometers to treat skin conditions such as vitiligo and psoriasis by promoting repigmentation and reducing inflammation.
This device is intended for use in medical institutions under physician supervision, supplied as a reusable medical instrument. It operates within regulatory classifications as a Class II device under FDA 510(k) clearance and MDD compliance, with models available for specific dermatological applications. Storage and handling follow standard medical device protocols to ensure safety and efficacy.
Frequently asked questions
What skin conditions is this 308nm Excimer Phototherapy Device primarily used to treat under physician supervision?
This device is designed to treat vitiligo and psoriasis by emitting narrowband ultraviolet B (UVB) radiation at 308 nanometers. The targeted phototherapy promotes repigmentation in vitiligo and reduces inflammation in psoriasis, though it must always be used under medical supervision in clinical settings.
Is this device single-use or reusable, and how should it be handled to maintain safety?
The 308nm Excimer Phototherapy Device is supplied as a reusable medical instrument, meaning it is intended for repeated use within a medical facility. Proper storage and handling must follow standard medical device protocols to ensure sterility and functionality between treatments, as outlined in the manufacturer’s guidelines.
What regulatory pathways has this device undergone, and how does that affect its use in clinical settings?
This device has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD), classifying it as a Class II device. These pathways confirm its safety and effectiveness for dermatological use under physician supervision, ensuring it meets regulatory standards for targeted phototherapy in medical institutions.
Are there different models available, and how might they differ in application?
Yes, this device comes in multiple models (CN-308E, KN-4003B3, KN-4003B4, KN-5000C/D/H/K), each potentially tailored for specific dermatological applications. While exact differences aren’t detailed here, the variations likely cater to different treatment parameters or patient needs, such as varying emission intensities or treatment areas, under the same core principle of 308nm UVB therapy.
How should this device be stored to preserve its performance and safety?
Since it is a reusable medical instrument, storage must adhere to standard protocols for UV-based devices to prevent degradation of the light source or contamination. The manufacturer’s instructions (not provided here) should specify environmental conditions—such as temperature, humidity, and protection from direct light—while ensuring it remains in a clean, sealed state when not in use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN ..., 308nm Excimer Phototherapy Device_UV Phototherapy, LED Photodynamic ..., 308nm Excimer Laser - FDA | Medical Device Navigator
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242977 | Class II | Active |
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Manufacturer
- Manufacturer
- Xuzhou Kernel Medical Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K242977 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026