Identifiers
- 510(k) Number
- K063025 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
- 5005 FDA 510(k)5005-E FDA 510(k)5005-C FDA 510(k)5005-150 FDA 510(k)5000-C-150 FDA 510(k)5005-E-C-150 FDA 510(k)5005-420 FDA 510(k)5005-C-420 FDA 510(k)5005-E-420 FDA 510(k)5005-E-C-420 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
LINA POWERBLADE - 5005-C by Lina Medical ApS — Class II — FDA_510K — listed in FDA 510(k) — 10 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063025 | Class II | Active |
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Manufacturer
- Manufacturer
- Lina Medical ApS
Sources (1)
- FDA 510(k) K063025 24 fields · synced Jun 18, 2026