HandPICO Fractional Laser Handpiece Tip

The handPICO Fractional Laser Handpiece Tip is an optical attachment for Vydence Medical's Etherea-MX and Zye lasers that produces 280 microbeams per cm² at 1064 nm in picosecond mode. It is indicated for tattoo removal on all skin types (treating black, brown, green, blue, and purple inks), treatment of benign pigmented lesions, acne scars, and wrinkles across various Fitzpatrick skin types.

The device operates at 1064 nm wavelength with a pulse duration of 530 picoseconds, maximum fluence of 3.0 mJ/microbeam, spot size of 6×6 mm, and repetition rate from single pulse to 10 Hz. Compared to predicates: fluence is within range (primary predicate 5.73 mJ/microbeam, secondary 2.9 mJ/microbeam), pulse duration differs by 80 ps from predicates (both 450 ps), beam diameter of 151 mm is within predicate ranges, and microbeam spacing of 600 µm matches the secondary predicate.

IEC 60601-1 Ed. 3.0 (medical device safety), IEC 60601-1-2 Ed. 4.0 (electromagnetic compatibility), IEC 60601-2-22:2007 (laser equipment requirements), ISO 14971 (risk management), and ISO 10993 (biocompatibility testing including cytotoxicity, sensitization, and irritation reactivity).

The handPICO has the same classification (Class II), same indications for use, and operates on the same principle (Q-switched Nd:YAG at 1064 nm) as both predicates. Although pulse duration is slightly longer (530 ps vs. 450 ps), this 80 ps difference is deemed acceptable. The fluence and beam characteristics fall within or closely match predicate ranges. Clinical histological testing showed no serious adverse events, and biocompatibility testing of patient-contact materials (sapphire, aluminum, acetal) met ISO 10993 standards, demonstrating equivalent safety and effectiveness.