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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 K262628
Device Name Picosecond Laser treatment system (Z180)
Applicant
Sanhe PERFECTLASER Technology Co., Ltd.
Rm. 1003, Bldg. A1 (A-1), Enterprise Headquarters, Yanjiao M
Langfang,  CN 065200
Applicant Contact Yongchao Lian
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd.
Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/29/2026
Decision Date 10/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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