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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 a medical device manufactured by Termosalud. It received FDA 510(k) clearance on 2023-06-08 under approval 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. It is manufactured by Termosalud. The 510(k) number is K230659.

When was Zionic Aesthetic approved by the FDA?

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

What company makes Zionic Aesthetic?

Zionic Aesthetic is manufactured by Termosalud.

What is the FDA product code for Zionic Aesthetic?

The FDA product code for Zionic Aesthetic is PBX.

Other Devices by Termosalud

K230412Symmed Elite Aesthetic K223680Eneka Pro K241656Eneka Selectif K243488VMAT PRO

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, 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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