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Dermalux Flex MD

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202028

by Aesthetic Technology, Ltd.

Identifiers

510(k) Number
K202028 FDA 510(k)
FDA Product Code
ILY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5500 FDA 510(k)
Regulation Number
890.5500 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dermalux Flex MD is a Light-Emitting Diode (LED) Device for skin rejuvenation and treatment of mild to moderate acne vulgaris, as classified under the Physical Medicine category. It delivers targeted light therapy to promote collagen production, reduce inflammation, and improve skin texture through specific wavelength emissions.

This device is supplied as a single-use or reusable (depending on manufacturer instructions) medical instrument, intended for use in clinical or professional settings such as dermatology clinics or aesthetic treatment centres. It operates under FDA 510(k) clearance and MDD compliance, with no explicit MRI safety restrictions noted. The device is available in a standard configuration, with no additional size or variant specifications provided.

Frequently asked questions

What specific skin conditions is the dermalux Flex MD designed to treat, and how does it work?

The dermalux Flex MD is designed for skin rejuvenation and mild to moderate acne vulgaris. It uses targeted Light-Emitting Diode (LED) therapy to stimulate collagen production, reduce inflammation, and improve skin texture by emitting specific wavelengths of light. This non-invasive approach helps address visible signs of aging and acne without surgical intervention.

Is the dermalux Flex MD intended for single-use or reusable applications, and how should it be handled?

The dermalux Flex MD can be used either as a single-use or reusable device, depending on the manufacturer’s instructions. If reusable, it must be cleaned and sterilized properly between uses to maintain hygiene and prevent cross-contamination. Always follow the manufacturer’s guidelines to ensure safe and effective operation.

What regulatory approvals does the dermalux Flex MD hold, and how does this affect its use?

The dermalux Flex MD holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it has been evaluated and deemed substantially equivalent to a legally marketed device in the U.S. and meets EU safety and performance standards. Clinicians can use it with confidence, knowing it meets these regulatory requirements.

Are there any size variations or additional configurations available for the dermalux Flex MD?

The dermalux Flex MD is supplied in a standard configuration only, with no additional size or variant specifications mentioned. This means it comes as a single model designed for general use in clinical or professional settings like dermatology clinics or aesthetic centers.

Can the dermalux Flex MD be used safely in environments where MRI machines are present?

There are no explicit MRI safety restrictions noted for the dermalux Flex MD, meaning it should not interfere with MRI operations if used in an MRI-compatible setting. However, always verify compatibility with the specific MRI system and follow facility protocols to ensure patient safety.

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
Aesthetic Technology, Ltd.

Sources (2)

  • FDA 510(k) K202028 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026