Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Dermalux EUDAMED
- Device Name
- Dermalux Tri-Wave MD EUDAMEDDermalux Flex MD EUDAMED
- Model / Reference
- 1000034 EUDAMED1000014 EUDAMED1000007 EUDAMED1000018 - Dermalux Tri-Wave MD EUDAMED1000018 EUDAMED1000032 EUDAMED1000046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060762460158 EUDAMED05060762460103 EUDAMED05060762460097 EUDAMED05060762460127 EUDAMED05060762460134 EUDAMED05060762460639 EUDAMED
- Basic UDI-DI
- B-05060762460158 EUDAMEDB-05060762460103 EUDAMEDB-05060762460097 EUDAMEDB-05060762460127 EUDAMEDB-05060762460134 EUDAMEDB-05060762460639 EUDAMED
- 510(k) Number
- K240222 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Market of Registration
- Denmark EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Dermalux Tri-Wave MD MKII (1000021) and Dermalux Compact MD (1000024) are LED-based phototherapy systems designed for aesthetic and dermatological treatments. These devices emit narrow-band light at 415nm (blue), 633nm (red), and 830nm (near-infrared) wavelengths to target specific skin conditions. The systems feature a main control unit with a capacitive touch screen and an articulated treatment head with 3 or 4 LED panels for precise application.
These devices are intended for use in clinical settings and are supplied as medical devices under FDA 510(k) clearance (K240222) and the Medical Devices Directive (MDD). They are reusable and require no sterility as they are not invasive. The Tri-Wave MD MKII and Compact MD are classified under product code GEX, with the Tri-Wave MD MKII featuring a larger treatment head compared to the Compact MD. Storage and operational details are manufacturer-specific, adhering to regulatory compliance standards.
Frequently asked questions
What are the key differences between the Dermalux Tri-Wave MD MKII and the Dermalux Compact MD in terms of design and application?
The Dermalux Tri-Wave MD MKII (1000021) features a larger treatment head with 4 LED panels, while the Dermalux Compact MD (1000024) has a smaller head with 3 LED panels. Both emit the same wavelengths (415nm blue, 633nm red, and 830nm near-infrared) for aesthetic and dermatological treatments, but the larger panel area on the MKII allows for broader or deeper skin coverage in a single session, making it suitable for larger treatment areas.
Are these devices single-use or reusable, and do they require sterilization before each use?
Both the Dermalux Tri-Wave MD MKII and Compact MD are reusable devices and are not classified as invasive, so they do not require sterilization between uses. Since they are designed for clinical settings, they should be cleaned and maintained according to the manufacturer’s instructions to ensure hygiene and longevity, but no sterilization process is specified.
What wavelengths of light do these devices emit, and how might they be used in dermatological treatments?
The devices emit three specific wavelengths: 415nm (blue light), 633nm (red light), and 830nm (near-infrared). These wavelengths are used to target different skin conditions—blue light is often employed for antibacterial effects (e.g., acne), red light for collagen stimulation and wound healing, and near-infrared for deeper tissue repair and anti-inflammatory benefits. The combination allows clinicians to customize treatments for issues like acne, rosacea, or skin rejuvenation.
How are these devices regulated, and what does the FDA 510(k) clearance (K240222) indicate about their safety and effectiveness?
The Dermalux Tri-Wave MD MKII and Compact MD hold FDA 510(k) clearance (K240222) under the Medical Devices Directive (MDD) in Europe, confirming they are deemed *substantially equivalent* to a legally marketed device. This clearance indicates that the FDA has reviewed the device’s design, performance, and labeling to ensure it is safe and effective for its intended clinical use—specifically, aesthetic and dermatological phototherapy—as described in the submission. It does not imply approval for specific conditions but confirms compliance with regulatory standards.
What storage and handling guidelines should be followed for these devices?
While the exact storage instructions are manufacturer-specific, the devices should be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and moisture to maintain functionality. Since they are reusable and not sterile, they should be kept in a designated clinical area with access restricted to authorized personnel. Always follow the manufacturer’s guidelines to ensure compliance with regulatory standards and device longevity.
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: Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024 ..., Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) by ..., Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) 510 ..., Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) 510 ...
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 | K240222 | Class II | Active |
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Manufacturer
- Manufacturer
- Aesthetic Technology, Ltd.
Sources (7)
- FDA 510(k) K240222 24 fields · synced Sep 18, 2026
- EUDAMED 4329b1ab-81d0-4d74-9930-e2bce43c7cc6 61 fields · synced Jul 8, 2026
- EUDAMED 0a8d04d2-c47d-4690-b34d-7f3eb62b6b9f 61 fields · synced Jul 9, 2026
- EUDAMED 6652a85f-990f-4124-a08b-93e5b60d6eca 61 fields · synced Jul 10, 2026
- EUDAMED ed302e10-2434-4405-a2fa-fcfbc42a28af 61 fields · synced Jul 14, 2026
- EUDAMED c0c426c0-4f74-41ea-94fa-7b4f5b213267 61 fields · synced Sep 18, 2026
- EUDAMED 96d1caa4-6e6b-4f9a-a1e6-d490cf9a1c31 61 fields · synced Sep 18, 2026