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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K250125
Device Name LMNT O2
Applicant
Xplr , Ltd.
Ben Ami 6 St., Tel Aviv, Israel
Ben Ami 6 St,  IL
Applicant Contact Izhaki Meital
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 805, # 19 Dongbao Rd., Songjiang Area, Shanghai
201613 China
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received01/17/2025
Decision Date 03/24/2025
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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