# K260256: Q-Switched Nd: YAG Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: May 4, 2026 after 96 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: 28 generations back to K943450 (1995). 583 ancestors in all.
No later device cites it as a predicate yet.
0 of 584 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202288: Finebeam, SNJ Co., Ltd. (2021) Summary page 6.
- K213569: HOLLYWOOD SPECTRA Laser System, Lutronic Corporation (2022) Summary page 6.
- K190936: Q-Switched Nd: YAG Laser System, Shanghai Apolo Medical Technology Co., Ltd. (2019) Summary page 6.

## 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 in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585nm and 650nm with optional dye handpieces): -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, - Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064nm in nanosecond mode (with QS, Q-PTP, Q-3, Q-4 function), including microbeam handpieces: -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. 1064nm in SPT mode: -Treatment of wrinkles, -Treatment of mild to moderate inflammatory acne vulgaris. 1064nm in LPS (Long pulse) mode: -Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin, -Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins, -Coagulation and hemostasis of soft tissue, -Treatment of wrinkles and acne vulgaris.

Source page: https://510kreport.com/device/K260256
Methodology: https://510kreport.com/methodology