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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K251544
Device Name Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
Applicant
Lakong Medical Devices Co., Ltd.
#13 Jingci Rd., Shilong, Dongguan, Guangdong
Dongguan,  CN 523326
Applicant Contact Zhongliang Wang
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 805, # 19 Dongbao Rd., Songjiang Area, Shanghai
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number872.6640
Classification Product Code
EIA  
Subsequent Product Code
KLC  
Date Received05/20/2025
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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