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Sign in to claim this brandMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA
US
Last updated May 31, 2026
What MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA makes
Medical San Industria de Equipamentos Médicos Ltda manufactures dermatological diode laser systems, including devices like the Liftendo and Liftendo 2.0 for skin treatments, as well as the Hakon and Hakon Smart for hair removal and skin rejuvenation procedures.
The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. 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 Medical San Industria de Equipamentos Médicos Ltda primarily manufacture?
Medical San Industria de Equipamentos Médicos Ltda specializes in dermatological diode laser systems. These devices are designed for skin treatments, including hair removal, skin rejuvenation, and procedures like those performed with the Liftendo, Liftendo 2.0, Hakon, and Hakon Smart. The focus is on non-invasive or minimally invasive cosmetic and dermatological applications.
Where is Medical San Industria de Equipamentos Médicos Ltda based?
The company is based in the United States. This location influences its regulatory compliance, particularly with U.S. authorities like the FDA, which governs the classification and authorization of its devices.
Which regulatory registries or databases list Medical San’s devices?
Medical San’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices like those manufactured by the company.
How are Medical San’s devices classified under U.S. regulations?
Medical San’s dermatological diode laser systems fall under FDA Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as pre-market notification (510(k)) clearance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 826828108
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medical San | Hakon | FDA UDI | Class II | Active |
| Medical San | Hakon Smart | FDA UDI | Class II | Active |
| Liftendo; Liftendo 2.0 | K241771 | FDA 510(k) | Class II | Active |
| Hakon, Hakon Smart | K231901 | FDA 510(k) | Class II | Active |
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