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Upgrade, Final TempSure System, Aesth&Surgical
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Upgrade, Final TempSure System, Aesth&Surgical FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Upgrade, Final TempSure System, Aesth&Surgical FDA UDI
- Model / Reference
- U100-7027-510 FDA UDI
- Description
- Upgrade, Final TempSure System, Aesth&Surgical FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494108397 FDA UDI
- 510(k) Number
- K182365 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Upgrade, Final TempSure System, Aesth&Surgical by Cynosure, LLC — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K182365 also covers:
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 77da84cc-8d00-4c2d-8f90-56cb4ef9c26e 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026