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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / August 2026 / K260387

510(k) cleared

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

Hironic Co., Ltd. · Aug 31, 2026 · K260387

FDA cleared the SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) from Hironic Co., Ltd. on Aug 31, 2026 under K260387, a traditional 510(k). The device falls under product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 6, 2026. The decision came 206 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hironic Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260397 (SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)), K251334 (NEW DOUBLO 2.0).

Questions & Answers

What did FDA clear under K260387?

K260387 is the FDA 510(k) for SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003), submitted by Hironic Co., Ltd.. FDA's decision date was Aug 31, 2026, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)?

Hironic Co., Ltd., based in Yongin-Si, is the applicant of record for K260387.

How long did the K260387 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on Aug 31, 2026, 206 days later.

← All decisions in August 2026

Sources