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Silhouette, Model 1000.01
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K070426
Identifiers
- 510(k) Number
- K070426 FDA 510(k)
- FDA Product Code
- FXN FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4160 FDA 510(k)
- Regulation Number
- 878.4160 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Silhouette, Model 1000.01 by Aranz Medical Limited — Class I — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K070426 | Class I | Active |
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Manufacturer
- Manufacturer
- Aranz Medical Limited
Sources (2)
- FDA 510(k) K070426 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026