Diode Laser Therapy Systems (WLA-02)

The Diode Laser Therapy Systems (WLA-02) is a medical device for dermatological procedures using controlled laser energy to target melanin or vascular structures. It features mixed wavelength (755 nm + 808 nm + 1064 nm) and single wavelength handpieces for temporary and permanent hair reduction, as well as treatment of benign vascular lesions, with integrated cooling to protect surrounding skin.

The device uses diode lasers at three wavelengths (755, 808, and 1064 nm) with fluence ranges of 0–120 J/cm² for 755/808 nm and 0–60 J/cm² for 1064 nm, frequency of 1–10 Hz, pulse width of 5–400 ms, and a spot size of 12×20 mm². Compared to predicates, it offers comparable wavelengths and operating parameters with selective photothermolysis as the working principle for both hair removal and vascular treatment.

Testing was conducted per ISO 10993-1:2018 for biocompatibility (cytotoxicity, sensitization, irritation); IEC 60601-1:2005+AMD, IEC 60601-1-2:2014+AMD, IEC 60601-2-22:2019, IEC TS 60601-4-2:2024, and IEC 60825-1:2014 for electrical safety and electromagnetic compatibility; and FDA's guidance on device software functions (June 14, 2023).

The Diode Laser Therapy Systems is substantially equivalent to five predicate devices (K222064, K251329, K172193, K170179, K191321) because it has identical indications for use, same patient population, comparable technological parameters, and uses the same selective photothermolysis working principle. Non-clinical testing (biocompatibility, electrical safety, software validation) confirmed the device is as safe and effective as predicates with no new safety or effectiveness concerns.