# K200746: IPL Treatment Systems

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: May 15, 2020 after 53 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: 11 generations back to K910422 (1992). 90 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093627: Ipulselight Ipl System, Models HS 300C and HS 650, Shanghai Apolo Medical Technologies Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K231394: Intense Pulsed Light System (2023), 2 descendants of its own
- K240482: Intense Pulsed Light System (ST-690) (2024), 1 descendant of its own
- K203395: Platform treatment system (2022), 1 descendant of its own
- K251545: Intense Pulsed Light Therapy Device (MMABM-1) (2025), 0 descendants of its own
- K240474: Multi-function Platform Systems   (BL-M10) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K200746
Methodology: https://510kreport.com/methodology