Plexr Plus
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Gmv S.R.L.
Identity
- Trade Name
- PLEXR PLUS EUDAMEDFDA UDI
- Generic Name
- Thermo-mechanical skin surface treatment system FDA UDI
- Device Name
- PLEXR PLUS EUDAMED
- Model / Reference
- PLEXR PLUS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057506440016 EUDAMEDFDA UDI
- Basic UDI-DI
- 805750644PPVS EUDAMED
- 510(k) Number
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- Z12010999 ELECTROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Thermo-mechanical skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Plexr Plus is a plasma soft surgery system classified as a Plasma Surgical Device (Product Code: GEI), designed to perform minimally invasive procedures using ionized gas. It is intended for dermatological applications, including the treatment of skin lesions, scars, and eyelid lifts without traditional cutting or surgical incisions.
Supplied as a reusable handheld device, the Plexr Plus is intended for use in clinical settings by trained medical professionals. Authorized under FDA 510K clearance (K210693) and MDR compliance, it is manufactured by GMV S.R.L. in Rome, Italy. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What types of dermatological procedures can the Plexr Plus be used for according to its intended purpose?
The Plexr Plus is designed for minimally invasive dermatological treatments, specifically for addressing skin lesions, scars, and eyelid lifts. It uses ionized gas to perform procedures without traditional cutting or surgical incisions, making it suitable for precise, non-invasive skin remodeling.
Is the Plexr Plus a single-use device or reusable, and how does this affect its clinical use?
The Plexr Plus is supplied as a reusable handheld device, meaning it is intended for repeated use in clinical settings by trained medical professionals. This design allows for cost-effective integration into existing workflows, though proper cleaning, maintenance, and sterilization protocols must be followed to ensure safety and efficacy between procedures.
How is the Plexr Plus regulated, and what does this mean for healthcare providers considering its use?
The Plexr Plus holds FDA 510(k) clearance (K210693) and complies with the EU Medical Device Regulation (MDR). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets EU safety and performance standards. Providers should confirm local compliance requirements and ensure staff are trained in its use before implementation.
What should clinicians know about the device’s supply and handling, particularly regarding sterility?
The Plexr Plus is a reusable handheld device, and while the data does not specify sterility requirements, it is critical for clinical settings to follow established protocols for cleaning, disinfection, and sterilization between uses. Since it is intended for surgical applications, adherence to infection control guidelines is essential to maintain patient safety and device integrity.
Does the Plexr Plus have any limitations or special considerations for storage or environmental use?
The provided data does not detail specific storage conditions or environmental limitations for the Plexr Plus. However, as a reusable medical device intended for clinical use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Clinicians should refer to the manufacturer’s instructions (GMV S.R.L.) for any additional handling or storage guidelines to preserve functionality and ensure longevity.
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: Plexr Plus - GMV Medical Innovation, Plexr Plus - Plasmatology Group, Plexr Plus - GMV Medical Innovation, Plexr® Plus — Plasma technology by GMV | ASEM
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210693 | Class II | Active |
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Manufacturer
- Manufacturer
- Gmv S.R.L.
Sources (3)
- FDA 510(k) K210693 24 fields · synced Oct 6, 2026
- FDA UDI 910aceb4-aff9-4764-b3ca-59e1f7b6ceda 33 fields · synced May 30, 2026
- EUDAMED 2ddddc37-1dbd-45a7-a642-b963fc6579f4 61 fields · synced Jul 16, 2026