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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 K242595
Device Name Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
Applicant
Shenzhen Greatro Electronic Technology Co., Ltd.
East Side, 4/F Bldg. A1, Xu'Xing'Da Industrial Park
Shiyan Sub-District, Bao'An District
Shenzhen,  CN 518108
Applicant Contact Xinhua Yue
Correspondent
Shenzhen Greatro Electronic Technology Co., Ltd.
East Side, 4/F Bldg. A1, Xu'Xing'Da Industrial Park
Shiyan Sub-District, Bao'An District
Shenzhen,  CN 518108
Correspondent Contact Lucy Yan
Regulation Number878.4810
Classification Product Code
OHT  
Date Received08/30/2024
Decision Date 11/07/2024
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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