Danish Dermatologic Development A/S
DK Last updated 22 Oct 2026
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- Devices
- 3
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Ellipse Flex Ppt, Model 9ESF7255 Ref K052688
Ellipse 12PL, Model 9ESL7228 Ref K060516
Ellipse Light Spt Ref K043255
What Danish Dermatologic Development A/S makes
Danish Dermatologic Development A/S manufactures dermatological devices, including the Ellipse Flex PPT (model 9ESF7255) and Ellipse 12PL (model 9ESL7228), which are designed for controlled skin treatments. Their portfolio also includes the Ellipse Light SPT, a device likely used for light-based dermatological procedures. These products are intended for professional use in medical settings.
The company’s devices fall under FDA Class II regulation and are listed via 510(k) clearance in the United States. The manufacturer is based in the US, and its products are tracked in the FDA’s 510(k) registry.
Frequently asked questions
What types of medical devices does Danish Dermatologic Development A/S manufacture?
Danish Dermatologic Development A/S specializes in dermatological devices. Their portfolio includes products like the Ellipse Flex PPT (model 9ESF7255), Ellipse 12PL (model 9ESL7228), and the Ellipse Light SPT, which are designed for controlled skin treatments and light-based dermatological procedures. These devices are intended for professional use in clinical settings.
Where is Danish Dermatologic Development A/S based?
The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and device listings confirm its operational presence in the US market.
How are Danish Dermatologic Development A/S’s devices classified by the FDA?
The company’s devices fall under FDA Class II classification, which means they are subject to special controls to ensure their safety and effectiveness. This classification is common for devices posing moderate risk, such as many dermatological instruments.
Which regulatory registries list Danish Dermatologic Development A/S’s devices?
The company’s devices are listed in the FDA’s 510(k) registry, which tracks cleared medical devices in the United States. The 510(k) process demonstrates that each device meets FDA requirements for safety and performance before being marketed.
Information
- Country
- DK