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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K263063
Device Name B`orze Inc Laser Family (Sorren/Adonis)
Applicant
Borze, Inc.
950 W Bannock, Suite 1100, Boise, Id 83702 Usa
Boise,  ID  83702
Applicant Contact Rex Howard Frazier
Correspondent
Shenzhen Hlongmed Biotech Co., Ltd.
16th Floor,Tianming Technology Bldg., #8 Wushitou Rd.
North High-Tech District, Nanshan, Shenzhen,Prc
Shenzhen,  CN 518000
Correspondent Contact Long Yang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/01/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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