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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 K241498
Device Name Diode laser Treatment System (K18)
Applicant
Hebei Keylaser Sci-Tech Co.,Ltd
4th Floor Bldg. C18-2, Hegu Industry Park
Chaoyang E. Rd., Zhuozhou
Baoding,  CN 072750
Applicant Contact Zhen Yang
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 Received05/28/2024
Decision Date 11/18/2024
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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