Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for: • Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. • Treatment of acne scars in Fitzpatrick Skin Types II-V. • Treatment of wrinkles in Fitzpatrick Skin Types I-IV.
The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for: • Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. • Treatment of acne scars in Fitzpatrick Skin Types II-V. • Treatment of wrinkles in Fitzpatrick Skin Types I-IV.
The handPICO® Fractional Laser Handpiece Tip is specifically designed for the ETHEREA MX and ZYE® LASERs manufactured by Vydence Medical Inc. The handPICO Fractional Handpiece Tip is a fractional optical element micro lens array that attaches to the handPICO handpiece, producing 280 microbeams/cm2 and a total of 100 microbeams spaced 600 µm apart.
Summary parsed at:2026-06-01 05:29:23 UTC
