ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)— 510(k) K254290

Substantially Equivalent

Shenzhen Peninsula Medical Group

FDA 510(k) clearance K254290 for ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III), Substantially Equivalent on 2026-01-30. Applicant: Shenzhen Peninsula Medical Group.

Clearance details

Applicant: Shenzhen Peninsula Medical Group
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2025-12-31
Decision date: 2026-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.