INTENSE PULSED LIGHT (IPL) SYSTEMS— 510(k) K122995

Name: FDA 510(k) clearance K122995
Creator: U.S. Food and Drug Administration
Published: 2013-01-22

Substantially Equivalent

Beijing Kes Biology Technology Co., Ltd.

FDA 510(k) clearance K122995 for INTENSE PULSED LIGHT (IPL) SYSTEMS, Substantially Equivalent on 2013-01-22. Applicant: Beijing Kes Biology Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Kes Biology Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2012-09-26
Decision date: 2013-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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 Beijing Kes Biology Technology Co., Ltd.

view all

K210168 — Diode Laser Therapy Systems2021-05-10
K193477 — Nd: YAG Laser Therapy Systems2020-06-24

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