| K-number | K241527 |
| Device name | Pastelle Pro |
| Applicant | Wontech Co., Ltd. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Feb 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The Pastelle Pro is an Nd:YAG laser system intended for aesthetic, cosmetic, and surgical applications requiring incision, excision, ablation, and vaporization of soft tissues in dermatology and general surgery. It operates at multiple wavelengths (1064nm, 532nm, 595nm, 660nm) in various pulse modes for treatments including tattoo removal, hair removal, pigmented lesion removal, vascular lesion treatment, acne scar resurfacing, and wrinkle treatment.
The device delivers laser energy at 1064nm, 532nm, 595nm, and 660nm wavelengths with output power ranging from 30–5,000mJ, pulse widths of 5–12ns (nanosecond mode) or up to 300µs (Genesis mode), and pulse repetition rates of 1–10Hz. It includes zoom handpieces (2–10mm), collimated handpieces (7mm), microbeam array handpieces, and optional dye handpieces. All optical specifications fall within or overlap the ranges of three predicate devices (K213569, K161670, K202503).
IEC 60601-1:2005/(R)2012 and A1:2012 (general safety), IEC 60601-1-6 Edition 3.1 2013 (essential performance), IEC 60601-2-22:2007/A:2012 (particular safety), IEC 60825-1 Edition 3.0 2014 (laser safety classification), IEC 60601-1-2:2014/A1:2020 (electromagnetic compatibility), and ISO 10993-1 (biocompatibility of handpiece tip material—aluminum powder, limited skin contact).
The Pastelle Pro operates on identical Nd:YAG laser principles and delivers substantially overlapping wavelengths, power outputs, pulse characteristics, and clinical indications as three legally marketed predicates. Each optical specification (zoom diameter, collimation, microbeam fluence, pulse width, repetition rate, and maximum fluence) was mapped to demonstrate it falls within or is bounded by corresponding predicate specifications. The device shares the same intended uses (tattoo removal, pigmented lesion treatment, vascular lesion treatment, hair removal, skin resurfacing) and delivery mechanism (articulated arm with interchangeable handpieces) as the predicates, with no material design differences that would adversely affect safety or effectiveness.
View the full FDA submission: accessdata.fda.gov