# K260375: Nd: YAG Laser Therapy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Sanhe Meditech Co., Ltd.
- Decided: Mar 31, 2026 after 54 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.
No later device cites it as a predicate yet.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202758: Nd: YAG Laser Therapy Systems HM-YL900, Shangdong Huamei Technology Co., Ltd. (2020) Summary page 6.

## Indications for use
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology, as follows: 532nm wavelength: ● Removal of light ink (red, sky blue, green, purple, and orange) tattoo. ● Treatment of benign vascular lesions including, but not limited to: telangiectasias. ● Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi, freckles, Nevus spilus, Seborrheic Keratoses. ● Treatment of Post Inflammatory Hyper-Pigmentation. 1064nm wavelength: ● Removal dark ink (black, blue and brown) tattoo. ● Removal of benign dermal pigmented lesions including, but not limited to: Nevus of Ota, Common Nevi, and Melasma. ● Removal or lightening of unwanted hair with or without adjuvant preparation. ● Skin resurfacing procedures for the treatment of acne scars and wrinkles.

Source page: https://510kreport.com/device/K260375
Methodology: https://510kreport.com/methodology