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Thermage FLX Body Tip, 16.00 cm2, 500 REP
EUDAMEDFDA UDIClass I (EU MDR)
Ref TT16.00F6-500Model Thermage FLX
Identity
- Trade Name
- Thermage FLX Body Tip, 16.00 cm2, 500 REP EUDAMEDTHERMAGE FLX FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Device Name
- FOOTSWITCH EUDAMEDFLX TREATMENT TIP, BODY, 16.0CM2, 1200 REP FDA UDI
- Model / Reference
- Thermage FLX EUDAMEDTT16.00F6-500 EUDAMEDFDA UDI
- Description
- FLX TREATMENT TIP, BODY, 16.0CM2, 1200 REP FDA UDI
Identifiers
- Catalog Number
- TT16.00F6-500 FDA UDI
- Primary DI / UDI-DI
- 00816995021360 EUDAMEDFDA UDI
- Basic UDI-DI
- 081699502B0014WD EUDAMED
- FDA Product Code
- ISA FDA UDIGEI FDA UDI
- EMDN Code
- V9015,V9099 EUDAMED
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5660 FDA UDI878.4400 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
Thermage FLX Body Tip, 16.00 cm2, 500 REP by Solta Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081699502B0014WD | 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 8d04b684-5d3a-4d69-94ab-96aa6fdab0cd 61 fields · synced Oct 6, 2026
- FDA UDI 4ae9ee97-28ff-4e0b-ac97-aa67ad67282d 34 fields · synced May 29, 2026