# K241527: Pastelle Pro

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Feb 14, 2025 after 260 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K943450 (1995). 305 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 309 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213569: HOLLYWOOD SPECTRA Laser System, Lutronic Corporation (2022) Summary page 6.
- K161670: Lucid Q-PTP / HWA 55, Bison Medical Co, Ltd. (2016) Summary page 7.
- K202503: Chrome, Quanta System Spa (2020) Summary page 7.

## Most influential descendants
- K253344: Bellus-Q (2025), 0 descendants of its own
- K251464: TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) (2025), 0 descendants of its own
- K250165: Pastelle (2025), 0 descendants of its own

## Indications for use
The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064nm in nanosecond mode, including microbeam handpieces: - Tattoo removal: dark ink (black, blue, and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of melasma 1064nm in Genesis (long-pulse) mode: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces): - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of Lentigines - Treatment of Café-au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyperpigmentation - Treatment of Becker's Nevi, Freckles, and Nevi spilus

Source page: https://510kreport.com/device/K241527
Methodology: https://510kreport.com/methodology