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FDA 510(k)

Zionic Pro Max (Radiofrequency)

K-Number: K243716 · 2025-05-28

ApplicantTermosalud S.L.
Decision Date2025-05-28
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Zionic Pro Max (Radiofrequency) is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud S.L.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K243716. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zionic Pro Max (Radiofrequency)?

Zionic Pro Max (Radiofrequency) is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Termosalud S.L.. The 510(k) number is K243716.

When did Zionic Pro Max (Radiofrequency) receive FDA 510(k) clearance?

Zionic Pro Max (Radiofrequency) received FDA 510(k) clearance on 2025-05-28, under 510(k) number K243716.

Who is the listed applicant for Zionic Pro Max (Radiofrequency)?

The FDA 510(k) record lists Termosalud S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zionic Pro Max (Radiofrequency)?

The FDA product code for Zionic Pro Max (Radiofrequency) is PBX.

Other records listing Termosalud S.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261473ChromixK253636Zionic Pro Max (EMS)

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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