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Advalight Aps

US Last updated 30 May 2026

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Devices
3
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue3

  • ADVATx 1.0 Ref 1.0

    Class II EUDAMEDFDA UDI Active

  • AdvaTx Ref K250189

    Class II FDA 510(k) Active

  • Advatx Ref K132976

    Class II FDA 510(k) Active

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • AdvaLight APS Ballerup Hovedstaden · DK FEI 3010683226

What Advalight Aps makes

Advalight Aps manufactures dermatological frequency-doubled solid-state laser systems designed for skin treatments. These devices are intended for procedures such as hair removal, pigmentation correction, and vascular lesion treatment, utilizing precise laser technology to target specific skin conditions.

The company’s portfolio is regulated under FDA Class II devices, with products listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Advalight Aps manufacture?

Advalight Aps specializes in dermatological frequency-doubled solid-state laser systems. These devices are engineered for skin treatments, including hair removal, pigmentation correction, and vascular lesion treatment. The technology relies on precise laser wavelengths to safely and effectively target specific skin conditions.

Where is Advalight Aps based?

Advalight Aps is headquartered in the United States. The company’s location is relevant for regulatory compliance and customer support, as it aligns with FDA oversight for its Class II devices.

Which regulatory registries list Advalight Aps’s devices?

Advalight Aps’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices.

How are Advalight Aps’s devices classified under U.S. regulations?

Advalight Aps’s dermatological laser systems fall under FDA Class II classification. This classification applies to devices posing moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Website
advalight.com
Phone
+4546965412
DUNS number
310762054