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Vaser Rf Wireless Footswitch
EUDAMEDFDA UDIClass I (EU MDR)
Ref P010338Model VaserLipo
Identity
- Trade Name
- VASER RF WIRELESS FOOTSWITCH EUDAMEDVASER FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- VENTX FOOTSWITCH EUDAMEDWIRELESS FOOT SWITCH (RF) FDA UDI
- Model / Reference
- VaserLipo EUDAMEDP010338 EUDAMEDP010338-03 FDA UDI
- Description
- WIRELESS FOOT SWITCH (RF) FDA UDI
Identifiers
- Catalog Number
- P010338-03 FDA UDI
- Primary DI / UDI-DI
- 00816995021513 EUDAMEDFDA UDI
- Basic UDI-DI
- 081699502B0012W9 EUDAMED
- FDA Product Code
- QPB FDA UDI
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic surgical system generator
Vaser Rf Wireless Footswitch by Solta Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasonic surgical system generator.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081699502B0012W9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Solta Medical, Inc.
- EUDAMED SRN
- US-MF-000018343
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 9ece9d0b-aec1-47bc-b86d-74b16577eaaa 61 fields · synced Jul 14, 2026
- FDA UDI 4c85aed6-488d-44b7-8fb3-822e601ec5a7 34 fields · synced May 30, 2026