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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 K221246
Device Name IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
Applicant
Shenzhen Semlamp Intelligent Technology Co., Ltd.
Rm. 915, Lankun Bldg., Minkang Rd. 213,
Zhangkeng Community, Minzhi Ave., Longhua
Shenzhen,  CN 518131
Applicant Contact Qi Wenjun
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number878.4810
Classification Product Code
OHT  
Date Received05/02/2022
Decision Date 07/07/2022
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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