Discovery Pico; Discovery Pico Plus; Discovery Pico Derm

The Discovery Pico Family comprises three multi-wavelength laser systems (Discovery Pico, Discovery Pico Plus, and Discovery Pico Derm) intended for aesthetic, cosmetic, and surgical dermatology applications. These devices deliver laser energy at multiple wavelengths (1064 nm, 532 nm, 694 nm in Q-switched and picosecond modes, plus optional IPL and 2940 nm sources) to treat benign vascular lesions, pigmented lesions, tattoos, unwanted hair, acne scars, and wrinkles across various skin types.

The subject device offers the same laser wavelengths and modes as its predicate (Quanta K191842) but with updated pulse duration ranges in picosecond mode: 1064 nm PS from 450–800 ps (versus 450 ps in the predicate) and 532 nm PS from 370–600 ps (versus 400 ps). Maximum fluence values are comparable or slightly lower (e.g., 1064 nm PS: 5.6 J/cm² vs. predicate's 10 J/cm²). Handpiece options, repetition rates, and overall thermal delivery mechanisms remain substantially identical to the predicate device.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (general medical electrical safety); IEC 60601-1-2:2014+AMD1:2020 (EMC); IEC 60601-2-22:2007+AMD1:2012 (laser equipment safety, including pulse duration accuracy per 2019 edition); IEC 60825-1:2014 (laser safety classification); IEC 62304:2006+AMD1:2015 (software lifecycle); ISO 10993-1:2009 (biocompatibility); ISO 17664-1:2021 (reprocessing/disinfection); IEC 60601-2-57:2011 (non-laser light source safety for IPL).

The subject device uses identical laser technology, wavelengths, and treatment modes as predicate K191842, with no changes to indications for use. Minor differences in pulse width ranges (higher upper limit at 1064 nm PS and lower limit at 532 nm PS) and slightly lower maximum fluence values do not raise new safety or effectiveness concerns because clinically relevant thermal effects depend on maximum fluence rather than pulse energy alone. All non-clinical bench testing per updated standards met acceptance criteria, confirming safe and effective operation within the same clinical application profile as the predicate.