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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 K253035
Device Name IPL Hair Removal Device (SYL001AZ, SYL002AZ)
Applicant
Gu'An Yeolight Smart Electronics Co., Ltd.
Rm. 203 Bldg. 1 Beside #12, Dongfang St.
High-Tech Zones, Gu'An
Langfang,  CN 065599
Applicant Contact Junrui Liu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90, Qianhai Rd.
Shenzhen,  CN 518082
Correspondent Contact Bing Huang
Regulation Number878.4810
Classification Product Code
OHT  
Date Received09/22/2025
Decision Date 11/19/2025
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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