# K250165: Pastelle

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Jul 3, 2025 after 163 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: 29 generations back to K943450 (1995). 307 ancestors in all.
No later device cites it as a predicate yet.
0 of 308 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123293: Pastelle Q-Switched ND: Yag Laser, Won Technology Co., Ltd. (2013) Summary page 7.
- K241527: Pastelle Pro, Wontech Co., Ltd. (2025). Our reading of the summary gave K241529, FDA’s number for Powered Wheelchair (NXN20-209) (Zhejiang Nysin Medical Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pastelle Pro”.
- K213569: HOLLYWOOD SPECTRA Laser System, Lutronic Corporation (2022) Summary page 7.

## Indications for use
The Pastelle laser 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/K250165
Methodology: https://510kreport.com/methodology