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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 K230060
Device Name Light Based Hair Removal Device GP592
Applicant
Shenzhen Gsd Tech Co., Ltd.
Bldg. A, Junsd Hi-Tech Park, W. Of Bao’An Rd.
Watch & Clock Base, Guangming District
Shenzhen,  CN 518106
Applicant Contact Huifang Yao
Correspondent
Shenzhen Gsd Tech Co., Ltd.
Bldg. A, Junsd Hi-Tech Park, W. Of Bao’An Rd.
Watch & Clock Base, Guangming District
Shenzhen,  CN 518106
Correspondent Contact Huifang Yao
Regulation Number878.4810
Classification Product Code
OHT  
Date Received01/09/2023
Decision Date 03/03/2023
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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