LYMA Laser PRO

The LYMA Laser PRO is a handheld, over-the-counter light-based device for treating facial wrinkles using low-level laser therapy. It contains three 808nm laser diodes and three red light-emitting diodes (LEDs) in a compact casing with a rechargeable battery, delivering infrared light across a treatment window to reduce wrinkle appearance.

The device treats a larger area (20.4 cm²) at higher irradiance (71 mW/cm²) than the primary predicate's 8.55 cm² and 62.5 mW/cm², but matches the secondary predicate's irradiance level. Both subject and primary predicate use identical 808 ± 2 nm laser diodes with identical materials and similar handheld design. Treatment regimen is the same: 3 minutes per area daily for 8 weeks, then 3 times weekly thereafter.

IEC 60601-1:2005/AMD1:2012/AMD2:2020 (electrical safety), IEC 60601-1-6:2010 (usability), IEC 60601-1-11:2015 (home healthcare), IEC 60601-2-22:2019 (laser equipment), IEC 60825-1:2014 (laser safety), IEC 60601-1-2:2014 (electromagnetic compatibility), and ISO 10993-1:2018 (biocompatibility).

The device has identical indications for use and materials to the primary predicate (K210823) and uses the same laser wavelength and design approach. While the subject device achieves higher irradiance and treats larger areas, these differences are not new safety or effectiveness questions because the output irradiance mirrors the secondary predicate (K230042) which was already cleared. Non-clinical testing confirms the device meets all applicable safety standards, demonstrating it performs equivalently without raising novel safety concerns.