Identity
- Trade Name
- Pelleve S5 FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- PELLEVE S5 RF GENERATOR 110V (MOCHA) FDA UDI
- Model / Reference
- IEC5P-ST/110 FDA UDI
- Description
- PELLEVE S5 RF GENERATOR 110V (MOCHA) FDA UDI
Identifiers
- Catalog Number
- IEC5P-ST/110 FDA UDI
- Primary DI / UDI-DI
- 00841494106713 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical 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
Yes
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: Electrosurgical system
Pelleve S5 by Cynosure, LLC — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cynosure, LLC
Sources (2)
- FDA UDI a22b4a0a-9d2a-4ea3-8462-b6be0e82e3aa 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026