510(k) K251545

Intense Pulsed Light Therapy Device (MMABM-1) by Micowey Medical Equipment (Guangxi) Co., Ltd. — Product Code ONF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 4, 2025
Date Received: May 20, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Device Class: Class II
Regulation Number: 878.4810
Review Panel: SU
Submission Type

A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.

Other clearances for product code ONF

K231952 — MEDILIGHT (September 3, 2025)
K243123 — IPL Treatment Device (MDSQMC-01) (July 3, 2025)
K250281 — DEKA LOTUS (February 26, 2025)
K242440 — Intense Pulsed Light Treatment System (LK-PT) (November 14, 2024)
K240314 — MULA (K2-A1) (August 21, 2024)
K240482 — Intense Pulsed Light System (ST-690) (May 17, 2024)
K233473 — DEKA LOTUS (May 16, 2024)
K233307 — Intensity Pulsed Light Therapy System (March 15, 2024)
K232708 — Intense pulsed light therapy device (December 1, 2023)
K232192 — Venus Versa PRO System (September 11, 2023)