HELIOS 785 Pico (1754V2)

The HELIOS 785 Pico is a Q-switched Nd:YAG laser system combined with a gain-switched Ti:Sapphire laser for surgical and dermatological use. It operates at three wavelengths (1064 nm, 532 nm, and 785 nm) to perform procedures including tattoo removal, hair removal, treatment of pigmented and vascular lesions, skin resurfacing, and soft tissue ablation across Fitzpatrick skin types I–VI.

The proposed device matches the primary predicate (K230373) in wavelengths, pulse durations, pulse energies, spot sizes, repetition rates, laser types, activation method, display, electrical power, beam delivery system, and physical dimensions. The proposed device adds new operating modes (RTP and FR modes at 1064 nm) with increased pulse energy (2.0 J and 3.0 J respectively) and expanded indications including treatment of melasma, acne scars, wrinkles, and pseudofolliculitis barbae.

Basic safety and essential performance per IEC 60601-1; electromagnetic compatibility per IEC 60601-1-2; laser safety per IEC 60825-1:2014; risk management per ISO 14971; usability per IEC 60601-1-6; and particular requirements for surgical and cosmetic laser equipment per IEC 60601-2-22.

The device uses substantially identical laser technology, optical design, and beam delivery as the predicate K230373 with matching core specifications. Although it introduces new operating modes and expanded indications, these enhancements do not alter the fundamental principles of operation or introduce new safety concerns, as they use the same wavelengths and similar pulse characteristics already established in the predicate's substantial equivalence.