# K251545: Intense Pulsed Light Therapy Device (MMABM-1)

- Pathway: 510(k) (Traditional)
- Applicant: Micowey Medical Equipment (Guangxi) Co., Ltd.
- Decided: Sep 4, 2025 after 107 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K910422 (1992). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240482: Intense Pulsed Light System (ST-690), Smedtrum Medical Technology Co., Ltd. (2024) Summary page 5.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 7.

## Indications for use
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions, with treatment filters applied as indicated: 420-1200nm and 515-1200nm: Moderate inflammatory acne vulgaris. 515-1200nm and 560-1200nm: Benign pigmented epidermal lesions (including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)). 515-1200nm and 560-1200nm: Benign cutaneous vascular lesions (including port wine stains, hemangiomas, facial, truncal, and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas, and venous malformations). 590-1200nm, 640-1200nm and 695-1200nm: Permanent hair reduction (long-term stable reduction in the number of hairs regrowing after a treatment regimen).

Source page: https://510kreport.com/device/K251545
Methodology: https://510kreport.com/methodology