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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 Hair Removal
510(k) Number K223524
Device Name IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
Applicant
Morlaser Shenzhen Co., Ltd.
313, 314, 315 & 4th Floor, Bldg. E, Tangtou #1
Industry District, Shiyan Town, Bao’An District
Shenzhen,  CN 518108
Applicant Contact Janny Shao
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
OHT  
Date Received11/23/2022
Decision Date 02/16/2023
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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