Identity
- Trade Name
- PLEXR PLUS FDA UDI
- Generic Name
- Thermo-mechanical skin surface treatment system FDA UDI
- Model / Reference
- PLEXR PLUS L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057506440085 FDA UDI
- 510(k) Number
- K210693 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Thermo-mechanical skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermo-mechanical skin surface treatment system
Plexr Plus by Gmv Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermo-mechanical skin surface treatment system.
- Tixel — NOVOXEL LTD · Class II
- Renuva 1550 — Wingderm Electro-Optics Ltd. · Class II
- LEAF — Gcs Co. Limited · Class I
- PLEXR PLUS — GMV SRL · Class II
- PLEXR PLUS — GMV SRL · Class II
Cleared under the same submission
K210693 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gmv Srl
Sources (1)
- FDA UDI d361af2e-7f30-4a39-8ef6-6e5e28df5589 33 fields · synced Jun 8, 2026