Identity
- Trade Name
- POTENZA EUDAMEDPOTENZA Tip FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- POTENZA Tip (Sterile micro needle electrode CP-25 Tip) FDA UDI
- Model / Reference
- POTENZA EUDAMED16 EUDAMEDCP-25 FDA UDI
- Description
- POTENZA Tip (Sterile micro needle electrode CP-25 Tip) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020101785 EUDAMED08800020105509 FDA UDI
- Basic UDI-DI
- B-08800020101785 EUDAMED
- 510(k) Number
- K201685 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Foot-switch, electrical
The Potenza is a radiofrequency (RF) microneedling device classified under nomenclature code Z12010902, designed for non-invasive skin rejuvenation. It delivers controlled RF energy through microneedles to stimulate collagen production, improve skin texture, and address mild to moderate skin laxity or scarring. The device operates without implantable components, medicinal administration, or animal-derived materials, adhering to Class IIb regulatory standards.
This single-use device is non-sterile and intended for professional use in clinical or aesthetic settings. It is not reusable or reprocessed and requires no special MRI safety considerations. Supplied as a standalone unit with a reference code of 16, it is authorized under FDA 510K and MDD directives. Storage and handling follow standard medical device protocols, with compliance ensured through a Basic UDI (B-08800020101785) and regulatory oversight by Emergo Europe B.V.
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Frequently asked questions
What is the primary purpose of the Potenza device and what skin concerns does it address?
The Potenza is designed for non-invasive skin rejuvenation using controlled radiofrequency (RF) energy delivered through microneedles. It stimulates collagen production to improve skin texture, reduce mild to moderate skin laxity, and address scarring. The device is intended for professional use in clinical or aesthetic settings to target these specific cosmetic concerns.
Is the Potenza device reusable or single-use, and how should it be handled after use?
The Potenza is a single-use device and is not intended for reuse or reprocessing. After use, it should be disposed of according to standard medical device waste protocols, as it is non-sterile and designed for one-time professional application.
What regulatory approvals does the Potenza device hold, and who oversees its compliance?
The Potenza is authorized under FDA 510K clearance and the Medical Device Directive (MDD). Its compliance is ensured through a Basic UDI (B-08800020101785) and is overseen by Emergo Europe B.V., which acts as the authorized representative for regulatory matters.
How is the Potenza device supplied, and what reference code should be used for ordering?
The Potenza is supplied as a standalone unit, with a reference code of 16 for ordering. It is intended for professional use in clinical or aesthetic settings and comes ready for immediate application without additional components.
Does the Potenza require any special storage conditions beyond standard medical device protocols?
The Potenza follows standard medical device storage and handling protocols. Since it is non-sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, as per general medical device guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Jeisys Medical Inc. | The Innovation Behind Potenza®, Jeisys | Product | POTENZA, Proven Potenza RF Microneedling Results | Jeisys Medical Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231216 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K201685 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K231287 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08800020101785 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jeisys Medical Inc.
- EUDAMED SRN
- KR-MF-000008513
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 495bc961-0a70-4828-bef2-e2a6f5ab8b90 61 fields · synced Sep 18, 2026
- FDA UDI 9c683600-f5c3-4ad3-9659-353f1ba9be08 34 fields · synced May 22, 2026
- FDA 510(k) K231216 1 fields · synced May 18, 2026