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308nm Excimer System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192642

by Chongqing Peninsula Medical Technology Co., Ltd.

Identifiers

510(k) Number
K192642 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 System is a dermatological ultraviolet light device classified as a Light, Ultraviolet, Dermatological device. It emits narrowband ultraviolet B (UVB) radiation at 308 nanometers, specifically designed for targeted phototherapy in skin conditions such as psoriasis and vitiligo. This excimer laser system delivers precise, localized treatment to affected areas, minimizing exposure to unaffected skin. Its mechanism relies on controlled UVB irradiation to modulate immune responses and promote repigmentation in vitiligo or reduce inflammatory plaques in psoriasis.

The system is intended for use in clinical dermatology settings and is supplied as a reusable medical device. It operates under regulatory oversight as a Class II device, with FDA 510(k) clearance (K192642) for substantial equivalence to predicate devices. Models XECL-308C and XECL-308D are identified by their respective product codes and registration numbers, adhering to FDA regulation 878.4630. Sterility and maintenance protocols are manufacturer-specified, though details are not provided in regulatory filings. The device is not labeled for MRI compatibility or single-use applications.

Frequently asked questions

What skin conditions is the 308nm Excimer System designed to treat?

The 308nm Excimer System is specifically designed for targeted phototherapy in dermatological conditions such as psoriasis and vitiligo. It uses narrowband ultraviolet B (UVB) radiation at 308 nanometers to modulate immune responses, reducing inflammatory plaques in psoriasis or promoting repigmentation in vitiligo. The device is intended for clinical use in dermatology settings where precise, localized treatment is required.

How is the 308nm Excimer System supplied and what are its models?

The 308nm Excimer System is supplied as a reusable medical device. Two primary models are available: the XECL-308C and the XECL-308D. These models are identified by their respective product codes and registration numbers, adhering to FDA regulation 878.4630. The system is not labeled for single-use applications, emphasizing its design for repeated clinical use under sterile conditions.

Is the 308nm Excimer System sterile and how should it be maintained?

The 308nm Excimer System is not explicitly labeled as sterile in the provided regulatory filings, meaning sterility protocols must be manufacturer-specified and followed by the clinical facility. Maintenance procedures are also outlined by the manufacturer to ensure proper functionality and safety. While details are not provided in the regulatory data, adherence to these protocols is critical for device performance and patient safety.

What regulatory approval does the 308nm Excimer System hold?

The 308nm Excimer System holds FDA 510(k) clearance (K192642) under the substantial equivalence pathway, classified as a Class II device. This clearance demonstrates that the device is substantially equivalent to a predicate device already on the market. The system is also registered under multiple FDA registration numbers, ensuring compliance with regulatory requirements for medical devices in dermatological applications.

Can the 308nm Excimer System be used in MRI environments?

The 308nm Excimer System is not labeled for MRI compatibility. This means it should not be used in or near MRI environments, as the device’s materials or components may interfere with MRI operations or pose risks to patients and staff. Always verify compatibility with MRI equipment before use in such settings.

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 System, 308NM Excimer System direct from Chongqing ..., Chongqing Peninsula Medical Technology Co., Ltd., Peninsula Medical Portable 308nm Excimer Laser System for Vitiligo ..., 308nm Excimer System XECL-308C, XECL-308D 308nm… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Chongqing Peninsula Medical Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K192642 24 fields · synced Oct 5, 2026