Intense Pulsed Light Treatment System— 510(k) K230816

Name: FDA 510(k) clearance K230816
Creator: U.S. Food and Drug Administration
Published: 2023-04-21

Substantially Equivalent

Shangdong Huamei Technology Co., Ltd.

FDA 510(k) clearance K230816 for Intense Pulsed Light Treatment System, Substantially Equivalent on 2023-04-21. Applicant: Shangdong Huamei Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shangdong Huamei Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2023-03-24
Decision date: 2023-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Weifang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONF

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K261204 — Intense Pulsed Light Therapy Device2026-06-12
K251545 — Intense Pulsed Light Therapy Device (MMABM-1)2025-09-04
K231952 — MEDILIGHT2025-09-03
K243123 — IPL Treatment Device (MDSQMC-01)2025-07-03
K250281 — DEKA LOTUS2025-02-26

More clearances from Shangdong Huamei Technology Co., Ltd.

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K202758 — Nd: YAG Laser Therapy Systems HM-YL9002020-11-16
K200751 — Photodynamic Therapy (PDT) Equipment2020-05-21
K192521 — Intense Pulsed Light Treatment System2019-12-06
K192528 — CO2 Laser Therapy System2019-12-03

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