| K-number | K252877 |
| Device name | SANDRO Dual |
| Applicant | Wontech Co., Ltd. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Dec 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The SANDRO Dual is a combination Nd:YAG and Alexandrite laser system indicated for hair reduction (temporary and permanent), treatment of benign pigmented lesions, wrinkles, vascular lesions, soft tissue coagulation, and temporary improvement of onychomycosis across all skin types (Fitzpatrick I-VI). It consists of a laser resonator, touch screen monitor, optical fiber handpiece, and foot switch.
The device operates at 755nm (Alexandrite) and 1064nm (Nd:YAG) wavelengths with laser outputs of 60J (755nm) and 90J (1064nm), pulse durations of 0.2-300ms, repetition rates of 0.5-10Hz, and spot sizes ranging from 2-25mm. All radiation diameters and pulse parameters fall within or are equivalent to predicate device ranges.
IEC 60601-1:2005/(R)2012 and A1:2012 (medical electrical equipment safety), IEC 60601-1-6 Edition 3.1 2013 (essential performance), IEC 60601-2-22:2007/A:2012 (particular requirements), IEC 60825-1 Edition 3.0 2014 (laser product safety), IEC 60601-1-2:2014/A1:2020 (electromagnetic compatibility), and ISO 10993 series (biocompatibility).
The SANDRO Dual is substantially equivalent to three predicate devices (K201111, K231791, K200110) as it shares identical indications for use, wavelengths, product code (GEX), design, and substantially similar technological characteristics. The device's performance parameters (laser output, pulse duration, spot sizes, and repetition rates) are within or exceed predicate specifications, and biocompatibility testing confirms safety for the intended skin contact application.
View the full FDA submission: accessdata.fda.gov