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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K260387
Device Name SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
Applicant
Hironic Co., Ltd.
19f, U-Tower, 767, Sinsu-Ro, Suji-Gu
Yongin-Si,  CN 16827
Applicant Contact Byoungkook Kim
Correspondent
Hironic Co., Ltd.
19f, U-Tower, 767, Sinsu-Ro, Suji-Gu
Yongin-Si,  CN 16827
Correspondent Contact Byoungkook Kim
Regulation Number882.5890
Classification Product Code
NFO  
Date Received02/06/2026
Decision Date 08/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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