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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 K261821
Device Name 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
Applicant
Zhengzhou PZ Laser Slim Technology Co., Ltd.
3rd Floor, Bldg. 1, # 101 Jinbai Rd., High-Tech Development
Zhengzhou,  CN
Applicant Contact Xiaopei Zhao
Correspondent
Zhengzhou PZ Laser Slim Technology Co., Ltd.
3rd Floor, Bldg. 1, # 101 Jinbai Rd., High-Tech Development
Zhengzhou,  CN
Correspondent Contact Xiaopei Zhao
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/01/2026
Decision Date 08/27/2026
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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