Intense pulsed light therapy device— 510(k) K232708

Name: FDA 510(k) clearance K232708
Creator: U.S. Food and Drug Administration
Published: 2023-12-01

Substantially Equivalent

Hebei Zhemai Technology Co., Ltd.

FDA 510(k) clearance K232708 for Intense pulsed light therapy device, Substantially Equivalent on 2023-12-01. Applicant: Hebei Zhemai Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hebei Zhemai Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2023-09-05
Decision date: 2023-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langfang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONF

view all

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 Hebei Zhemai Technology Co., Ltd.

view all

K232709 — Diode laser therapy device2023-11-30
K232716 — Q-Switched Nd:Yag laser2023-11-30

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