K254290
- 510(k) number
- K254290
- Device name
- ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
- Applicant
- Shenzhen Peninsula Medical Group CN
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-01-30
- Date received
- 2025-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K254290.pdf
Official FDA record: K254290
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.