Apollo Duet (Model : APD-4000)— 510(k) K212253

Substantially Equivalent

Weero Co.

FDA 510(k) clearance K212253 for Apollo Duet (Model : APD-4000), Substantially Equivalent on 2022-08-25. Applicant: Weero Co.. Device class: 2.

Clearance details

Applicant: Weero Co.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2021-07-19
Decision date: 2022-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

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K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

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