Pastelle

The Pastelle is a Q-switched Nd:YAG laser system intended for aesthetic, cosmetic, and surgical applications requiring soft tissue incision, excision, ablation, and vaporization. It operates at 1064nm and 532nm wavelengths in multiple modes (nanosecond, Genesis long-pulse, and microbeam) for dermatological and general surgical procedures including tattoo removal, hair removal, skin resurfacing, and treatment of various pigmented lesions and vascular conditions.

The device uses an Nd:YAG laser head with two laser media and xenon flash lamps in a water-cooled housing, delivering laser energy at 1064nm (up to 3500mJ Genesis mode, up to 1600mJ PTP mode, up to 1300mJ nanosecond mode) and 532nm (up to 500mJ nanosecond mode). Handpiece options include zoom (2–10mm diameter), collimation, microbeam/DOE arrays, and dye converters. Pulse widths range from 4–480ns depending on mode, with repetition rates up to 10Hz.

IEC 60601-1:2005/AMD2:2020 (medical electrical equipment general safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-1-6:2010/AMD2:2020 (usability), IEC 60601-2-22:2019 (surgical laser equipment), IEC 60825-1:2014 (laser safety), and ISO 10993-1 (biocompatibility for aluminium handpiece tip).

The Pastelle is substantially equivalent because it uses the same Nd:YAG laser technology and architecture as the predicate devices (Pastelle K123293, Pastelle Pro K241529, and HOLLYWOOD SPECTRA K213569), shares identical intended uses across all treatment modalities, and operates within the performance envelope (power, pulse width, repetition rate, spot sizes) covered by all three predicates. The specifications overlap or are subsumed by existing predicate parameters, demonstrating no new or different safety or effectiveness concerns.