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ZenTite (Unicorn+) +3 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K254290
Identifiers
- 510(k) Number
- K254290 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
- ZenTite (Unicorn+) FDA 510(k)ZenTite (Unicorn+I) FDA 510(k)ZenTite (Unicorn+II) FDA 510(k)ZenTite (Unicorn+III) 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)
ZenTite (Unicorn+) +3 more models by Shenzhen Peninsula Medical Group — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K254290 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Peninsula Medical Group
Sources (1)
- FDA 510(k) K254290 24 fields · synced Jun 18, 2026