Zionic Aesthetic— 510(k) K230659

Substantially Equivalent

Termosalud

FDA 510(k) clearance K230659 for Zionic Aesthetic, Substantially Equivalent on 2023-06-08. Applicant: Termosalud. Device class: 2.

Clearance details

Applicant: Termosalud
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2023-03-09
Decision date: 2023-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gijon, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

More clearances from Termosalud

K243488 — VMAT PRO2025-02-06
K241656 — Eneka Selectif2024-08-12
K230412 — Symmed Elite Aesthetic2023-04-13
K223680 — Eneka Pro2023-02-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.