# K231952: Medilight

- Pathway: 510(k) (Special)
- Applicant: Medicreations, LLC
- Decided: Sep 3, 2025 after 796 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 MediLight device (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. Skin Types Conditions | I | II | III hair removal | 640-1200, 690-1200 | 640-1200, 690-1200 | 640-1200, 690-1200 pigmented lesions | 480-1200, 530-1200 | 480-1200, 530-1200 | 480-1200, 530-1200 vascular lesions | 530-1200, 590-1200 | 530-1200, 590-1200 | 530-1200, 590-1200 Filter setting and wavelength range

Source page: https://510kreport.com/device/K231952
Methodology: https://510kreport.com/methodology