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Sign in to claim this brandProllenium Medical
US
Last updated May 24, 2026
What Prollenium Medical makes
Prollenium Medical manufactures tissue injection cannulas designed for precision dermal procedures, including the SoftFil® Precision and SoftFil® EasyGuide models. Their portfolio also includes microbe-derived and bioabsorbable synthetic polymer materials for dermal reconstruction, such as Revanesse Lips+ with Lidocaine and Revanesse Versa, which incorporate anaesthetic agents. Additionally, they produce reusable hot/cold therapy packs for localized temperature therapy.
The company’s devices are regulated under FDA’s classification system, with products falling into Class I and Class III categories. These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. 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 Prollenium Medical manufacture?
Prollenium Medical specializes in devices for dermal procedures and tissue reconstruction. Their portfolio includes tissue injection cannulas like the SoftFil® Precision and SoftFil® EasyGuide, designed for precision in cosmetic or medical injections. They also produce dermal reconstructive materials, such as Revanesse Lips+ with Lidocaine (a microbe-derived material with anaesthetic) and Revanesse Versa (a bioabsorbable synthetic polymer). Additionally, they offer reusable hot/cold therapy packs for localized temperature therapy.
Where is Prollenium Medical based, and how does that affect their regulatory standing?
Prollenium Medical is based in the United States, which means their devices are subject to U.S. regulatory requirements, including those set by the FDA. Since they manufacture Class I and Class III devices, their products must comply with FDA regulations, including listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and adherence to U.S. medical device standards.
Which regulatory registries or databases list Prollenium Medical’s devices?
Prollenium Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and ensuring compliance with U.S. medical device regulations, as it provides transparency on device identification, manufacturing information, and regulatory status for authorized products.
How are Prollenium Medical’s devices classified under FDA regulations?
Prollenium Medical’s devices fall into two FDA classification categories: Class I and Class III. Class I devices generally pose minimal risk and may require general controls, while Class III devices are higher risk and typically require premarket approval due to their potential for serious adverse health effects. The classification depends on the device’s intended use and risk profile, as outlined in FDA guidelines.
Why do some of Prollenium Medical’s devices include anaesthetic agents?
Some of Prollenium Medical’s dermal reconstructive materials, like Revanesse Lips+ with Lidocaine, incorporate anaesthetic agents to minimize patient discomfort during procedures. The inclusion of anaesthetics is designed to enhance patient experience by reducing pain or irritation associated with injections or treatments, particularly in sensitive areas like the lips or face.
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
- 247326606
Catalogue (48)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SoftFil® Precision | CP2540U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2350U | FDA UDI | Class I | Active |
| Revanesse Lips+ with Lidocaine 1.2 mL | 40149 | FDA UDI | Class III | Active |
| SoftFil® Precision | CP2550U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2330U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2240U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2370U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP1670U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2250U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2330U | FDA UDI | Class I | Active |
| Revanesse Versa 1.0mL | 40081 | FDA UDI | N/A | Active |
| SoftFil® EasyGuide | CEGS2550U | FDA UDI | Class I | Active |
| MICROFILL 25G x 50mm | PN56044 | FDA UDI | Class I | Unknown |
| SoftFil® Precision | CP2270U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2550U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP3025U | FDA UDI | Class I | Active |
| MICROFILL 27G x 38mm | PN56046 | FDA UDI | Class I | Unknown |
| SoftFil® Precision | CP2613U | FDA UDI | Class I | Active |
| MICROFILL 22G x 70mm | PN56042 | FDA UDI | Class I | Unknown |
| SoftFil® Precision | CP2070U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2725U | FDA UDI | Class I | Active |
| MICROFILL 30G x 25mm | PN56048 | FDA UDI | Class I | Unknown |
| SoftFil® Precision | CP2290U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP1490U | FDA UDI | Class I | Active |
| MICROFILL 25G x 38mm | PN56043 | FDA UDI | Class I | Unknown |
| Revanesse Versa+ with Lidocaine 1.0 mL | 40082 | FDA UDI | N/A | Active |
| SoftFil® Precision | CP1870U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2540U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2750U | FDA UDI | Class I | Active |
| MICROFILL 30G x 40mm | PN56049 | FDA UDI | Class I | Unknown |
| MICROFILL 27G x 50mm | PN56047 | FDA UDI | Class I | Unknown |
| Revanesse Lips+ with Lidocaine 1.0 mL | 40144 | FDA UDI | N/A | Active |
| MICROFILL 22G x 50mm | PN56041 | FDA UDI | Class I | Unknown |
| Revanesse Gel Pack | PN99802 | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2560U | FDA UDI | Class I | Active |
| Revanesse Versa+ with Lidocaine 1.2 mL | 40083 | FDA UDI | N/A | Active |
| SoftFil® Precision | CP2350U | FDA UDI | Class I | Active |
| Revanesse Versa 1.2 mL | 40089 | FDA UDI | N/A | Active |
| SoftFil® Precision | CP2090U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2250U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP1890U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP1690U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2530U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2550U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2740U | FDA UDI | Class I | Active |
| SoftFil® Precision | CP2740U | FDA UDI | Class I | Active |
| SoftFil® EasyGuide | CEGS2560U | FDA UDI | Class I | Active |
| MICROFILL 27G x 25mm | PN56045 | FDA UDI | Class I | Unknown |
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