# K173038: CuRAS Nd:YAG Laser

- Pathway: 510(k) (Traditional)
- Applicant: Ilooda Co,., Ltd.
- Decided: Dec 1, 2017 after 64 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: 14 generations back to K910422 (1992). 130 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122922: E-Beam ND: Yag Laser, Eclipse Aesthetics, LLC (2013) Summary page 4.

## Most influential descendants
- K193477: Nd: YAG Laser Therapy Systems (2020), 2 descendants of its own
- K253123: CuRAS hybrid (2025), 0 descendants of its own
- K252319: Q-Switched Nd: YAG Laser machine (LFS-C13U) (2025), 0 descendants of its own
- K231948: Mediyag (2024), 0 descendants of its own
- K232532: Nd:Yag Laser Therapy Systems (2023), 0 descendants of its own

## Indications for use
The CuRAS Nd;YAG laser system in 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 Pigmented Lesions - Removal of Minor 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/K173038
Methodology: https://510kreport.com/methodology