Picosecond Nd:YAG Laser Systems (Model: HS-298)

The Picosecond Nd:YAG Laser System (HS-298) is a solid-state laser device intended for surgical and aesthetic use in dermatology and general/plastic surgery. It produces pulsed near-infrared (1064nm) and visible (532nm) light delivered via an articulated arm and handpiece to remove tattoos on various skin types and treat benign pigmented lesions.

The device operates at 532nm and 1064nm wavelengths with pulse durations of 300–500 picoseconds and repetition rates of 1–10 Hz. Maximum output energy ranges from 200–500 mJ depending on handpiece type (Zoom, MLA, or DOE). Spot sizes range from 2–10mm. These specifications match or are covered by predicate devices K200116, K241144, and K234104.

The device was tested against IEC 60601-1:2005+A1:2012+A2:2020 (medical electrical equipment general safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-2-22:2019 (surgical and therapeutic laser equipment), and IEC 60825-1:2014 (laser product safety and classification).

The indications for use are identical to the predicates. All key technological parameters—wavelengths, pulse duration, repetition rate, spot size, and energy output—are either identical to or fall within the range of predicates K200116, K241144, and K234104. Performance testing demonstrates compliance with applicable safety and performance standards, establishing substantial equivalence.