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FDA 510(k)

Zionic Aesthetic

K-Number: K230659 · 2023-06-08

ApplicantTermosalud
Decision Date2023-06-08
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Zionic Aesthetic is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K230659. 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 Aesthetic?

Zionic Aesthetic is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Termosalud. The 510(k) number is K230659.

When did Zionic Aesthetic receive FDA 510(k) clearance?

Zionic Aesthetic received FDA 510(k) clearance on 2023-06-08, under 510(k) number K230659.

Who is the listed applicant for Zionic Aesthetic?

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

What is the FDA product code for Zionic Aesthetic?

The FDA product code for Zionic Aesthetic is PBX.

Other records listing Termosalud 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.

K243488VMAT PROK241656Eneka SelectifK230412Symmed Elite AestheticK223680Eneka Pro

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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