Identity
- Trade Name
- Vsmooth applicator FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- Vsmooth Applicator, VelaShape III FDA UDI
- Model / Reference
- FG71171 FDA UDI
- Description
- Vsmooth Applicator, VelaShape III FDA UDI
Identifiers
- Catalog Number
- FG71171 FDA UDI
- Primary DI / UDI-DI
- 00817495022789 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Multi-modality skin/body contouring 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: Multi-modality skin/body contouring system
Vsmooth applicator by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality skin/body contouring system.
- STOP X — POLLOGEN LTD · Class II
- STOP VX MODEL U — POLLOGEN LTD · Class II
- BC Small Applicator — VIORA LTD · Class I
- FC Applicator — VIORA LTD · Class II
- PURE DentA — ENDYMED MEDICAL LTD · Class II
- V-FORM — VIORA LTD · Class I
- EndyMed PRO mini-shaper Handpiece — ENDYMED MEDICAL LTD · Class II
- EndyMed Pro iFine Handpiece — ENDYMED MEDICAL LTD · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Candela Corporation
Sources (1)
- FDA UDI 2b3a4733-1df4-4d05-9873-30e55a8a7bab 35 fields · synced Jun 8, 2026