Identity
- Trade Name
- SA Small Repl. Cover 10x13mm, 4Hr, Velashape III FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- SA Small Repl. Cover 10x13mm, 4Hr, Velashape III FDA UDI
- Model / Reference
- AS83322 FDA UDI
- Description
- SA Small Repl. Cover 10x13mm, 4Hr, Velashape III FDA UDI
Identifiers
- Catalog Number
- AS83322 FDA UDI
- Primary DI / UDI-DI
- 00817495024516 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-modality skin/body contouring system
SA Small Repl. Cover 10x13mm, 4Hr, Velashape III 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 ee33e7fb-884f-4cbc-897a-66e463b7ec5b 35 fields · synced Jun 8, 2026