Is this your brand? Sign in to claim ownership.
Sign in to claim this brandEllipse A/S
US
Last updated May 27, 2026
What Ellipse A/S makes
Ellipse A/S manufactures multi-modality skin treatment systems designed for dermatological applications, including laser beam guiding handpieces and intense pulsed light devices. These systems are used for procedures such as hair removal, vascular lesion treatment, and skin rejuvenation, targeting conditions like rosacea, pigmentation, and acne scars. The portfolio includes standalone devices like the HRL 600 and VL555, as well as integrated systems such as the Ellipse Sirius USA and Frax 1550 for precise tissue treatment.
The company’s devices fall under FDA Class II regulation, requiring premarket notification (510(k)) clearance and inclusion in the FDA’s Unique Device Identifier (UDI) system. These products are listed under the FDA’s regulatory pathways, ensuring compliance with U.S. medical device standards. Ellipse A/S operates from the United States, adhering to domestic regulatory requirements for skin treatment technologies.
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 Ellipse A/S manufacture?
Ellipse A/S specializes in dermatological devices designed for skin surface treatment. Their portfolio includes multi-modality systems like the Ellipse Sirius USA, which combine multiple technologies, as well as standalone devices such as the HRL 600 (a dermatological laser beam guiding handpiece) and the VL555 (an intense pulsed light system). These devices are primarily used for procedures like hair removal, vascular lesion treatment, and skin rejuvenation, addressing conditions such as rosacea, pigmentation, and acne scars.
Where is Ellipse A/S based, and how does this affect its regulatory compliance?
Ellipse A/S is based in the United States, which means its devices must comply with FDA regulations. Since these devices fall under Class II classification, they require premarket notification (510(k)) clearance and must be listed in the FDA’s Unique Device Identifier (UDI) system. The company’s U.S. headquarters ensures alignment with domestic regulatory requirements for dermatological laser and light-based treatments.
Which regulatory registries or databases list Ellipse A/S’s devices?
Ellipse A/S’s devices are listed in the FDA’s 510(k) Premarket Notification database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm that each device has undergone the necessary regulatory review process for Class II medical devices in the U.S., ensuring traceability and compliance with FDA standards.
How are Ellipse A/S’s devices classified under FDA regulations?
All of Ellipse A/S’s devices fall under FDA Class II classification, which applies to moderately high-risk medical devices requiring special controls to ensure safety and effectiveness. This classification mandates premarket notification (510(k)) clearance before commercial distribution, ensuring that each device meets regulatory standards for dermatological laser and light-based treatments before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- candelamedical.com
- —
- —
- [email protected]
- Phone
- +4545768808
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 305006145
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ellipse | Sirius | FDA UDI | Class II | Active |
| Ellipse | Nordlys | FDA UDI | Class II | Active |
| Hrl 600 | 9APP7745 | FDA UDI | Class II | Active |
| Ellipse Nordlys USA | 9SYS7751 | FDA UDI | Class II | Active |
| Vl555 | 9APP7747 | FDA UDI | Class II | Active |
| Ellipse Sirius USA | 9SYS7773 | FDA UDI | Class II | Active |
| Pl 400 | 9APP7749 | FDA UDI | Class II | Active |
| Vls 555 | 9APP7814 | FDA UDI | Class II | Active |
| Frax 1550 | 9APP7829 | FDA UDI | Class II | Active |
| Ellipse | Ydun | FDA UDI | Class II | Active |
| Hrd 645 | 9APP7746 | FDA UDI | Class II | Active |
| Frax 1550 | 9APP7829 | FDA UDI | Class II | Active |
| Pr 530 | 9APP7748 | FDA UDI | Class II | Active |
| Ellipse | Ydun | FDA UDI | Class II | Active |
| Ellipse | Ydun | FDA UDI | Class II | Active |
| Prs 530 | 9APP7815 | FDA UDI | Class II | Active |
| Hrd 645 | 9APP7746 | FDA UDI | Class II | Active |
| Nd:YAG Nordlys | 9APP7750 | FDA UDI | Class II | Active |
| ydun | 9SYS7852 | FDA UDI | Class II | Active |
| Nd:YAG MultiFlex | 9APP7472 | FDA UDI | Class II | Active |
| Ellipse Nordlys | 9SYS7751 | FDA UDI | Class II | Active |
| Ellipse | Nordlys | FDA UDI | Class II | Active |
| Ellipse Sirius | 9SYS7773 | FDA UDI | Class II | Active |
| Hrl 600 | 9APP7745 | FDA UDI | Class II | Active |
| Ellipse Ydun | K180406 | FDA 510(k) | Class II | Active |
| Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | K161162 | FDA 510(k) | Class II | Active |
| Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | K150907 | FDA 510(k) | Class II | Active |
| Ellipse Multiflex | K081408 | FDA 510(k) | Class II | Active |
| Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun | K192951 | FDA 510(k) | Class II | Active |
| Ellipse I2pl+/Ellipse Multiflex+ | K140670 | FDA 510(k) | Class II | Active |
| Ellipse Juvia, Model 9eju7465 | K072023 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.