Identity
- Trade Name
- xeo SA EUDAMEDFDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- xeo SA EUDAMEDxeo SA IPL System FDA UDI
- Model / Reference
- XEOSA EUDAMEDxeo SA FDA UDI
- Description
- xeo SA IPL System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816722021113 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816722021113 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
xeo SA by Cutera, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00816722021113 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cutera, Inc.
- EUDAMED SRN
- US-MF-000010456
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 70f7a57c-bafb-4b2b-9e51-0bc713576d3b 61 fields · synced Jun 19, 2026
- FDA UDI f1cd1cdb-ce28-4973-9a0e-92accfa46402 34 fields · synced May 30, 2026