510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260387Substantially Equivalent

SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)

Hironic Co., Ltd., Yongin-Si, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(206 days to decision)
Product code
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Hironic Co., Ltd. 19f, U-Tower, 767, Sinsu-Ro, Suji-Gu, Yongin-Si, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFO

Trailing 12 months
9 clearances under product code NFO in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NFO, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20260
May 20262
June 20261
July 20261
August 20261
September 20262
October 20260