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Sign in to claim this brandLIPOGEMS INTERNATIONAL SPA
US
Last updated May 27, 2026
What LIPOGEMS INTERNATIONAL SPA makes
Lipogems International SPA manufactures kits and devices for the noninvasive processing of autologous adipose tissue, including specialized trays and procedure sets tailored for sports medicine, beauty, orthopedic, and surgical applications. Their portfolio includes standalone processing devices and modular kits designed to prepare fat-derived cells for therapeutic or cosmetic use, such as tissue regeneration or soft-tissue augmentation.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer is based in the United States, adhering to U.S. regulatory requirements for these device categories.
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 Lipogems International SPA primarily manufacture?
Lipogems International SPA specializes in devices and kits for the noninvasive processing of autologous adipose tissue. Their products are designed to prepare fat-derived cells for therapeutic or cosmetic applications, such as tissue regeneration or soft-tissue augmentation. The company offers standalone processing devices and modular kits tailored for specific uses, including sports medicine, beauty, orthopedic procedures, and surgery.
Where is Lipogems International SPA based, and how does this affect its regulatory compliance?
Lipogems International SPA is based in the United States, which means its devices must comply with U.S. regulatory standards. Since their products fall under the category of autologous adipose tissue processing, they are classified as Class II medical devices under FDA regulations. This classification requires adherence to specific U.S. guidelines for safety, performance, and manufacturing practices.
Which regulatory registries or databases list Lipogems International SPA’s devices?
Lipogems International SPA’s devices are listed in the FDA’s 510(k) database, which tracks premarket submissions for Class II medical devices, and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for devices authorized under U.S. regulations, including those used for adipose tissue processing.
How are Lipogems International SPA’s devices classified under FDA regulations?
Lipogems International SPA’s devices are classified as Class II medical devices by the FDA. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. The classification ensures that these devices undergo rigorous evaluation, including performance testing and manufacturing oversight, before authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- lipogems.com
- —
- —
- [email protected]
- Phone
- +390237072408
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 431081002
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lipogems Sport Medicine Kit 240 | LG MK 240 | FDA UDI | N/A | Active |
| Lipogems Sport Medicine Kit 60 | LG MK 60 | FDA UDI | N/A | Active |
| Lipogems Beauty Kit 120 + Tray | LG BK 120 T | FDA UDI | N/A | Active |
| Lipogems Beauty Kit 240 + Tray | LG BK 240 T | FDA UDI | N/A | Active |
| Lipogems Surgery Kit 240 + Tray | LG SK 240 T | FDA UDI | N/A | Active |
| LG PT 12 - Lipogems Procedure Tray | LG PT 12 | FDA UDI | Class II | Active |
| Lipogems Ortho Kit 240 + Tray | LG OK 240 T | FDA UDI | N/A | Active |
| Lipogems Ortho Kit 60 | LG OK 60 | FDA UDI | N/A | Active |
| Lipogems Process Device 60 O | LGD 60 | FDA UDI | Class II | Active |
| LG PT 14 - Lipogems Procedure Tray | LG PT 14 | FDA UDI | Class II | Active |
| Lipogems Ortho Kit 240 | LG OK 240 | FDA UDI | N/A | Active |
| Lipogems Beauty Kit 60 + Tray | LG BK 60 T | FDA UDI | N/A | Active |
| Lipogems Beauty Kit 240 | LG BK 240 | FDA UDI | N/A | Active |
| Lipogems Ortho Kit 120 + Tray | LG OK 120 T | FDA UDI | N/A | Active |
| Lipogems Surgery Kit 60 + Tray | LG SK 60 T | FDA UDI | N/A | Active |
| Lipogems Surgery Kit 240 | LG SK 240 | FDA UDI | N/A | Active |
| Lipogems Process Device 60 M | LGD 60 | FDA UDI | Class II | Active |
| Lipogems Sport Medicine Kit 240 + Tray | LG MK 240 T | FDA UDI | N/A | Active |
| Lipogems Process Device 240 S | LGD 240 | FDA UDI | Class II | Active |
| Lipogems Sport Medicine Kit 120 + Tray | LG MK 120 T | FDA UDI | N/A | Active |
| Lipogems Sport Medicine Kit 60 + Tray | LG MK 60 T | FDA UDI | N/A | Active |
| Lipogems Ortho Kit 60 + Tray | LG OK 60 T | FDA UDI | N/A | Active |
| Lipogems Beauty Kit 60 | LG BK 60 | FDA UDI | N/A | Active |
| LG PT 15 - Lipogems Procedure Tray | LG PT 15 | FDA UDI | Class II | Active |
| Lipogems Surgery Kit 60 | LG SK 60 | FDA UDI | N/A | Active |
| Lipogems Surgery Kit 120 + Tray | LG SK 120 T | FDA UDI | N/A | Active |
| Lipogems Process Device 120 O | LGD 120 | FDA UDI | Class II | Active |
| The Lipogems System | K142682 | FDA 510(k) | Class II | Active |
| Lipogems System | K161636 | FDA 510(k) | Class II | Active |
| Lipogems System | K171135 | FDA 510(k) | Class II | Active |
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