# K193477: Nd: YAG Laser Therapy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Kes Biology Technology Co., Ltd.
- Decided: Jun 24, 2020 after 191 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: 15 generations back to K910422 (1992). 131 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173038: CuRAS Nd:YAG Laser, Ilooda Co,., Ltd. (2017) Summary page 4.

## Most influential descendants
- K231948: Mediyag (2024), 0 descendants of its own
- K232532: Nd:Yag Laser Therapy Systems (2023), 0 descendants of its own

## Indications for use
The device is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm wavelength: -Tattoo removal: light ink(red, tan, purple, orange, skyblue, green) -Removal of Epidermal Benign Pigmented Lesions -Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias -Treatment of Lentigines -Treatment of Cafe-Au-Lait -Treatment of Seborrheic Keratoses -Treatment of Post Inflammatory Hyper-Pigmentation -Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: -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 wrinkle

Source page: https://510kreport.com/device/K193477
Methodology: https://510kreport.com/methodology