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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 K252732
Device Name 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
Applicant
Zhengzhou PZ Laser Slim Technology Co., Ltd.
3rd Floor, Bldg. 1, # 101 Jinbai Rd., High-Tech
Dev. Zone, 450001 Zhengzhou City, Henan Province
Zhengzhou,  CN
Applicant Contact Yueming Li
Correspondent
Zhengzhou PZ Laser Slim Technology Co., Ltd.
3rd Floor, Bldg. 1, # 101 Jinbai Rd., High-Tech
Dev. Zone, 450001 Zhengzhou City, Henan Province
Zhengzhou,  CN
Correspondent Contact Yueming Li
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/28/2025
Decision Date 10/23/2025
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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