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Sign in to claim this brandNorseld Pty., Ltd.
US
Last updated May 23, 2026
What Norseld Pty., Ltd. makes
Norseld Pty., Ltd. manufactures dermatological laser beam guiding handpieces, including copper bromide lasers and dual yellow lasers (e.g., Model D10B). These devices are designed for skin treatments, such as hair removal, pigmentation correction, and vascular lesion therapy.
The company’s products are classified as Class II medical devices and are listed under FDA’s 510(k) and UDI registries. The manufacturer operates from 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 Norseld Pty., Ltd. manufacture?
Norseld Pty., Ltd. specializes in dermatological laser beam guiding handpieces, including copper bromide lasers and dual yellow lasers like the Model D10B. These devices are primarily used for skin treatments such as hair removal, pigmentation correction, and vascular lesion therapy.
Where is Norseld Pty., Ltd. based?
Norseld Pty., Ltd. is based in the United States. The company’s location is relevant for regulatory oversight and compliance, particularly for devices listed under U.S. regulatory frameworks.
Which regulatory registries list Norseld Pty., Ltd.’s devices?
Norseld Pty., Ltd.’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations.
How are Norseld Pty., Ltd.’s devices classified under U.S. regulations?
Norseld Pty., Ltd.’s dermatological laser handpieces, such as copper bromide and dual yellow lasers, are classified as Class II medical devices. This classification typically indicates moderate risk and requires specific controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Copper Bromide Laser | D10B Dual Yellow | FDA UDI | Class II | Active |
| Dual Yellow Laser, Model Dual Yellow D10b | K032397 | FDA 510(k) | Class II | Active |
| Dual Yellow Laser, Model D10b | K023899 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Norseld Pty. Ltd. ADELAIDE South Australia · AU FEI 3008965332