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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 K260518
Device Name IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
Applicant
Shenzhen Semlamp Intelligent Technology Co., Ltd.
Rm. 2017-20, Shenbaomao Bldg., Minqiang Community, Minzhi St
Shenzhen,  CN 518131
Applicant Contact Wenjun Qi
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu Distr
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number878.4810
Classification Product Code
OHT  
Date Received02/17/2026
Decision Date 04/21/2026
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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