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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K260318
Device Name 4K NIR/ICG Imaging System
Applicant
Zhejiang Healnoc Technology Co., Ltd.
Rm.1201, 12th Floor, Bldg. 3, # 580, Liye Rd.
Changhe Subdistrict, Binjiang District
Hangzhou,  CN 310056
Applicant Contact QiongHua Wei
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz., W. Guangzhong Rd. 555,
Shanghai,  CN
Correspondent Contact Kyra Kang
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
IZI  
Date Received01/30/2026
Decision Date 05/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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