Boston Pico755

The Boston Pico755 is a solid-state laser surgical instrument indicated for removal of tattoos and benign pigmented lesions (including Ota nevus, Hori spots, and melasma). With specific handpieces, it is also indicated for treatment of acne scars and wrinkles in skin types I-IV. The device is intended for use by trained physicians in professional healthcare facilities.

The Boston Pico755 operates at 755nm wavelength with 450ps (±20%) pulse duration, comparable to the predicate's 500-900ps. It offers single and repeat pulse modes at 1, 2.5, 5, and 10 Hz with maximum pulse energy of 300mJ across most handpieces and maximum fluence of 6.37 J/cm² (comparable to predicate). Eight interchangeable handpieces provide treatment spot diameters ranging from 2-10mm, and the device uses aluminum alloy patient-contacting material versus the predicate's stainless steel.

IEC 60601-1:2005 and amendments (medical electrical equipment general requirements); IEC 60601-2-22:2019 (surgical and therapeutic laser equipment); IEC 60825-1:2014 (laser safety); IEC 60601-1-2:2014 (electromagnetic compatibility); ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, and systemic toxicity).

The subject device and predicate device (PicoSure Workstation, K210226) have identical intended uses and comparable technological characteristics despite minor differences in pulse duration, materials, and specifications. Bench testing demonstrated the subject device met performance specifications comparable to the predicate across all handpieces. Animal studies showed equivalent safety and efficacy for black tattoo removal. These results collectively support substantial equivalence without raising different safety or effectiveness questions.