Vydence Medical Industria E Commercio Ltda · Class II · Cleared Jan 24, 2026
| K-number | K252753 |
| Device name | Vydence Family of Lasers |
| Applicant | Vydence Medical Industria E Commercio Ltda |
| Product code | GEX |
| Device class | Class II |
| Decision date | Jan 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The Vydence Family of Lasers is a configurable multi-platform laser surgical system with up to nine different handpieces offering multiple modalities including IPL (intense pulsed light) and infrared handpieces, plus various wavelength laser options (1064nm, 532nm, 1540nm, 2940nm, 1340nm, and 755nm). It is intended for use in dermatology, plastic surgery, and general surgery to treat conditions such as acne, pigmented lesions, vascular lesions, tattoos, unwanted hair, and wrinkles.
The technological characteristics are substantially the same as the predicate devices. The sole exception is the Zye Ultra configuration, which includes new software and a novel blended mode feature that sequentially emits 755nm alexandrite and 1064nm Nd:YAG laser energy.
Electrical safety and EMC testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1, and IEC 60601-2-22. Software validation testing was also performed.
The Vydence Family is substantially equivalent to its predicate devices because it maintains the same design, intended use, principles of operation, and technological characteristics. The minor difference in software and the blended mode feature in the Zye Ultra do not raise new safety or effectiveness questions. Non-clinical testing supports safe and effective use for the proposed indications.
View the full FDA submission: accessdata.fda.gov