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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 K251339
Device Name Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Applicant
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Rm. 201, 2nd Floor, Bldg. 2, #52 Hongsong Rd.
High-Tech Development Zone,  CN 450001
Applicant Contact Xiaojie Shi
Correspondent
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Rm. 201, 2nd Floor, Bldg. 2, #52 Hongsong Rd.
High-Tech Development Zone,  CN 450001
Correspondent Contact Xiaojie Shi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/30/2025
Decision Date 07/25/2025
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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