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GME ExSys 308

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K150752

by GME German Medical Engineering GmbH

Identifiers

510(k) Number
K150752 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 GME ExSys 308 is a dermatological ultraviolet light device designed for medical and aesthetic applications. Classified as a light-emitting excimer device operating at 308 nm, it is intended for targeted dermatological treatments, including conditions requiring ultraviolet radiation therapy.

This device is supplied as a reusable medical instrument and is classified under the FDA as a Class II device. It is authorized under the FDA 510(k) pathway and the European Medical Device Directive (MDD). The GME ExSys 308 is intended for use in clinical settings, adhering to regulatory standards for ultraviolet dermatological devices, and requires proper maintenance and calibration as specified by the manufacturer.

Frequently asked questions

What types of dermatological conditions is the GME ExSys 308 designed to treat, and how does its 308 nm wavelength play a role in therapy?

The GME ExSys 308 is a dermatological ultraviolet light device specifically designed for targeted treatments requiring ultraviolet radiation therapy, such as certain skin conditions. Its 308 nm wavelength is characteristic of excimer lamps, which are commonly used for precision treatments like psoriasis, vitiligo, and other photodermatologic disorders. The wavelength allows for localized therapy with reduced risk to surrounding healthy tissue, making it suitable for controlled medical and aesthetic dermatological applications.

Is the GME ExSys 308 a single-use device, or is it intended for reuse in a clinical setting? What maintenance does it require?

The GME ExSys 308 is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Since it is classified as a reusable device, it requires proper maintenance and calibration as outlined by the manufacturer to ensure safety, efficacy, and compliance with regulatory standards. Regular servicing, including cleaning and technical checks, is essential to maintain performance and longevity.

What regulatory pathways has the GME ExSys 308 followed for market authorization, and which governing bodies have approved it?

The GME ExSys 308 has been authorized through the FDA 510(k) pathway in the United States, where it was deemed *substantially equivalent* to a predicate device, and under the European Medical Device Directive (MDD) in Europe. These pathways confirm its compliance with regulatory standards for ultraviolet dermatological devices, ensuring it meets safety and performance requirements for clinical use.

How is the GME ExSys 308 classified under FDA regulations, and what does this classification imply for its use in medical settings?

The GME ExSys 308 is classified as a Class II device by the FDA, which indicates it poses moderate risk and requires special controls beyond general controls to ensure its safety and effectiveness. This classification implies that while it is not as high-risk as a Class III device, it still requires validation of performance, proper labeling, and adherence to manufacturing practices to maintain regulatory compliance in clinical settings.

What is the intended clinical specialty for the GME ExSys 308, and how might this influence its adoption in healthcare facilities?

The GME ExSys 308 is primarily associated with the General and Plastic Surgery specialties, as indicated in its regulatory filings. This suggests it is most commonly used in dermatology clinics, surgical centers, or specialized dermatological units where ultraviolet radiation therapy is applied for targeted skin treatments. Facilities with expertise in photodermatology or reconstructive procedures may find it particularly useful for conditions requiring precise excimer light therapy.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
GME German Medical Engineering GmbH
FDA Applicant
Gme (German Medical Engineering) GmbH

Sources (2)

  • FDA 510(k) K150752 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026