# K233307: Intensity Pulsed Light Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Adss Development Co., Ltd.
- Decided: Mar 15, 2024 after 168 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Intensity Pulsed Light Therapy System is intended for medical use in the treatment of the following conditions: -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. -Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.

Source page: https://510kreport.com/device/K233307
Methodology: https://510kreport.com/methodology