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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K254290
Device Name ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
Applicant
Shenzhen Peninsula Medical Group
101 1 F Block B, 3f Block B, 3f Block A, Bldg, F2 Changfeng
Industrial Park, Liuxian 3rd Rd., 68# Xin'An St., Bao'An Dis
Shenzhen,  CN 518100
Applicant Contact Chunyan Zhang
Correspondent
Shenzhen Peninsula Medical Group
101 1 F Block B, 3f Block B, 3f Block A, Bldg, F2 Changfeng
Industrial Park, Liuxian 3rd Rd., 68# Xin'An St. Bao'An Dist
Shenzhen,  CN 518100
Correspondent Contact Chunyan Zhang
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
PBX  
Date Received12/31/2025
Decision Date 01/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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