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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Light Induced Heating
510(k) Number K261582
Device Name Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
Applicant
Zhengzhou PZ Laser Slim Technology Co., Ltd.
3rd Floor, Bldg. 1, #101 Jinbai Rd., High-Tech Development Z
Zhengzhou,  CN 450001
Applicant Contact Junmei Li
Correspondent
Zhengzhou PZ Laser Slim Technology Co., Ltd.
3rd Floor, Bldg. 1, #101 Jinbai Rd., High-Tech Development Z
Zhengzhou,  CN 450001
Correspondent Contact Junmei Li
Regulation Number878.4810
Classification Product Code
NUV  
Subsequent Product Codes
ISA   PBX  
Date Received05/13/2026
Decision Date 08/28/2026
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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