Boston PICO (Boston PICO)

The Boston PICO is a multi-wavelength picosecond laser system indicated for surgical and cosmetic use in dermatology, general surgery, and plastic surgery departments. It removes tattoos at 1064 nm (all Fitzpatrick skin types I-VI in black, brown, green, blue, purple) and 532 nm (Fitzpatrick I-III in red, yellow, orange), treats benign pigmented skin lesions, and uses microbeam handpieces for wrinkle treatment on skin types I-IV.

The Boston PICO delivers energy at 1064 nm and 532 nm wavelengths with 250 ps pulse duration (±20%), comparable pulse energies (Zoom 1064: 500 mJ, 532: 250 mJ), fluence ranges of 0.12–15.7 J/cm² (1064) and 0.06–7.6 J/cm² (532), spot sizes 2–10 mm, and maximum pulse power up to 2.0 GW (1064) and 1.0 GW (532). These specifications are comparable to the predicate PicoWay Laser System, though with variations in pulse duration range (predicate: 240–500 ps) and pulse power.

IEC 60601-1:2005 and amendments (medical electrical equipment safety), IEC 60601-2-22:2019 (laser equipment requirements), IEC 60825-1:2014 (laser product safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), ISO 10993-5/10/23/11 (biocompatibility testing), and FDA 06/14/2023 guidance for device software functions at Basic Documentation Level.

The Boston PICO and predicate device (PicoWay K191685) share identical intended use for tattoo removal and pigmented lesion treatment across comparable skin types and wavelengths. Although technological differences exist (e.g., pulse duration range, power specifications, handpiece designs), these do not raise new safety or effectiveness concerns. Ex vivo and animal testing confirmed mechanism of action and safety; biocompatibility testing showed user-contacting materials are non-toxic, non-irritating, and non-sensitizing. All performance tests met acceptance criteria, supporting substantial equivalence.