# K190936: Q-Switched Nd: YAG Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Jun 17, 2019 after 68 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: 13 generations back to K910422 (1992). 129 ancestors in all.
4 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)
- K113588: Spectra Laser System, Lutronic Corporation (2012) Summary page 4.

## Most influential descendants
- K202758: Nd: YAG Laser Therapy Systems HM-YL900 (2020), 2 descendants of its own
- K260256: Q-Switched Nd: YAG Laser Systems (2026), 0 descendants of its own
- K260375: Nd: YAG Laser Therapy Systems (2026), 0 descendants of its own
- K252515: Q-Switched Nd:Yag laser (K690) (2025), 0 descendants of its own

## Indications for use
The Q-Switched Nd: YAG Laser System 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 (nominal delivered energy of 585nm and 650nm with optional dye handpiece): - 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/K190936
Methodology: https://510kreport.com/methodology