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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 K222800
Device Name Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Applicant
Sanhe Laserconn Tech Co., Ltd.
X03-A Bldg., Baishijingu Industry Park, Yanjiao
Langfang,  CN 065201
Applicant Contact Xia Aijiang
Correspondent
Bonnier Quality Supervision Consulting (Jm) Center
Hailunxinyuan #3203, Jianghai District
Jiangmen,  CN 529000
Correspondent Contact Gary Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/16/2022
Decision Date 11/07/2022
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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