IPL Treatment Systems— 510(k) K200746

Name: FDA 510(k) clearance K200746
Creator: U.S. Food and Drug Administration
Published: 2020-05-15

Substantially Equivalent

Shanghai Apolo Medical Technology Co., Ltd.

FDA 510(k) clearance K200746 for IPL Treatment Systems, Substantially Equivalent on 2020-05-15. Applicant: Shanghai Apolo Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Apolo Medical Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2020-03-23
Decision date: 2020-05-15
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 Shanghai Apolo Medical Technology Co., Ltd.

view all

K260256 — Q-Switched Nd: YAG Laser Systems2026-05-04
K260017 — Picosecond Nd:YAG Laser Systems (Model: HS-298)2026-04-09
K251031 — Fiber Laser Treatment Systems (HS-232,HS-233)2025-07-02
K232409 — Electromagnetic Stimulation Systems2024-04-10
K221770 — Fiber Laser Treatment System2022-10-13

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