| K-number | K231952 |
| Device name | MEDILIGHT |
| Applicant | Medicreations, LLC |
| Product code | ONF |
| Device class | Class II |
| Decision date | Sep 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The MediLight is a laser surgical instrument using pulsed-light energy for aesthetic and surgical applications. It is indicated for permanent hair removal, reduction of benign pigmented lesions, and reduction of benign vascular lesions across skin types I, II, and III, with filter settings and wavelength ranges of 640-1200 nm and 690-1200 nm for hair removal, 480-1200 nm and 530-1200 nm for pigmented lesions, and 530-1200 nm and 590-1200 nm for vascular lesions.
Not stated in this summary.
Not stated in this summary.
The device was determined to be substantially equivalent to legally marketed predicate devices that predate the Medical Device Amendments (May 28, 1976) or to reclassified devices. The 510(k) submission demonstrates substantial equivalence based on the intended use in surgical, aesthetic applications using pulsed-light technology for the three specified clinical indications, which aligns with established predicate laser surgical instruments in the same regulatory classification (Class II, 21 CFR 878.4810) and product code (ONF).
View the full FDA submission: accessdata.fda.gov