# K231394: Intense Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Smedtrum Medical Technology Co., Ltd.
- Decided: Aug 9, 2023 after 86 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: 12 generations back to K910422 (1992). 91 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200746: IPL Treatment Systems, Shanghai Apolo Medical Technology Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K240482: Intense Pulsed Light System (ST-690) (2024), 1 descendant of its own
- K251545: Intense Pulsed Light Therapy Device (MMABM-1) (2025), 0 descendants of its own

## Indications for use
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions: 1. Moderate inflammatory acne vulgaris; 2. Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); 3. Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations; 4. Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.

Source page: https://510kreport.com/device/K231394
Methodology: https://510kreport.com/methodology